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NCT0000xxxx/NCT00000102.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000102</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR01070-0506</org_study_id>
<secondary_id>M01RR001070</secondary_id>
<nct_id>NCT00000102</nct_id>
</id_info>
<brief_title>Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication children
take to treat congenital adrenal hyperplasia (CAH).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This protocol is designed to assess both acute and chronic effects of the calcium channel
antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine
the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels,
as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II
is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release
by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA
axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid
treatment in CAH.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Congenital Adrenal Hyperplasia</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Nifedipine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- diagnosed with Congenital Adrenal Hyperplasia (CAH)

- normal ECG during baseline evaluation

Exclusion Criteria:

- history of liver disease, or elevated liver function tests

- history of cardiovascular disease
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>14 Years</minimum_age>
<maximum_age>35 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Medical University of South Carolina</name>
<address>
<city>Charleston</city>
<state>South Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>January 2004</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
<mesh_term>Adrenogenital Syndrome</mesh_term>
<mesh_term>Adrenocortical Hyperfunction</mesh_term>
<mesh_term>Hyperplasia</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Nifedipine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000102
org study id: NCRR-M01RR01070-0506
secondary id: M01RR001070
nct id: NCT00000102
lead sponsor:
This study will test the ability of extended release nifedipine (Procardia XL), a blood
pressure medication, to permit a decrease in the dose of glucocorticoid medication children
take to treat congenital adrenal hyperplasia (CAH).
This protocol is designed to assess both acute and chronic effects of the calcium channel
antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine
the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels,
as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II
is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release
by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA
axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid
treatment in CAH.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Nifedipine
criteria:
gender: All
minimum age: 14 Years
maximum age: 35 Years
healthy volunteers: No
facility:
country: United States
mesh term: Adrenal Hyperplasia, Congenital
mesh term: Adrenogenital Syndrome
mesh term: Adrenocortical Hyperfunction
mesh term: Hyperplasia
mesh term: Nifedipine
|
NCT0000xxxx/NCT00000104.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000104</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00400-0587</org_study_id>
<secondary_id>M01RR000400</secondary_id>
<nct_id>NCT00000104</nct_id>
</id_info>
<brief_title>Does Lead Burden Alter Neuropsychological Development?</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>HRSA/Maternal and Child Health Bureau</agency>
<agency_class>U.S. Fed</agency_class>
</collaborator>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Inner city children are at an increased risk for lead overburden. This in turn affects
cognitive functioning. However, the underlying neuropsychological effects of lead overburden
and its age-specific effects have not been well delineated. This study is part of a larger
study on the effects of lead overburden on the development of attention and memory. The
larger study is using a multi-model approach to study the effects of lead overburden on these
effects including the event-related potential (ERP), electrophysiologic measures of attention
and memory are studied. Every eight months, for a total of three sessions the subjects will
complete ERP measures of attention and memory which require them to watch various computer
images while wearing scalp electrodes recording from 11 sites. It is this test that we are
going to be doing on CRC. There will be 30 lead overburdened children recruited from the
larger study for participation in the ERP studies on CRC. These 30 children will be matched
with 30 children without lead overburden. This portion of the study is important in providing
an index of physiological functioning to be used along with behaviorally based measures of
attention and memory, and for providing information about the different measures.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Defined Population</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<condition>Lead Poisoning</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>ERP measures of attention and memory</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject
recruitment will take place in local clinics which serve pregnant women and offspring
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>0 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Department of Neurology 420 Delaware St. SE, Box 486 Mayo</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>lead overburden</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Poisoning</mesh_term>
<mesh_term>Lead Poisoning</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000104
org study id: NCRR-M01RR00400-0587
secondary id: M01RR000400
nct id: NCT00000104
lead sponsor:
collaborator:
Inner city children are at an increased risk for lead overburden. This in turn affects
cognitive functioning. However, the underlying neuropsychological effects of lead overburden
and its age-specific effects have not been well delineated. This study is part of a larger
study on the effects of lead overburden on the development of attention and memory. The
larger study is using a multi-model approach to study the effects of lead overburden on these
effects including the event-related potential (ERP), electrophysiologic measures of attention
and memory are studied. Every eight months, for a total of three sessions the subjects will
complete ERP measures of attention and memory which require them to watch various computer
images while wearing scalp electrodes recording from 11 sites. It is this test that we are
going to be doing on CRC. There will be 30 lead overburdened children recruited from the
larger study for participation in the ERP studies on CRC. These 30 children will be matched
with 30 children without lead overburden. This portion of the study is important in providing
an index of physiological functioning to be used along with behaviorally based measures of
attention and memory, and for providing information about the different measures.
observational model: Defined Population
time perspective: Other
intervention type: Procedure
intervention name: ERP measures of attention and memory
criteria:
gender: Female
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Poisoning
mesh term: Lead Poisoning
|
NCT0000xxxx/NCT00000105.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000105</url>
</required_header>
<id_info>
<org_study_id>2002LS032</org_study_id>
<secondary_id>MT1999-06</secondary_id>
<nct_id>NCT00000105</nct_id>
</id_info>
<brief_title>Vaccination With Tetanus and KLH to Assess Immune Responses.</brief_title>
<official_title>Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses</official_title>
<sponsors>
<lead_sponsor>
<agency>Masonic Cancer Center, University of Minnesota</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Masonic Cancer Center, University of Minnesota</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to learn how the immune system works in response to vaccines. We
will give the vaccines to subjects who have cancer but have not had treatment, and to
patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines
while they are on treatments which boost the immune system (like the immune stimulating drug
interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting
drugs, we do not yet know if they improve the body's immune system to respond better to a
vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control
subjects to get a good measure of the normal immune response. We will compare the patients
and the healthy volunteers to study how their immune systems respond to the vaccines.

There are several different types of white cells in the blood. We are interested in immune
cells in the blood called T-cells. These T-cells detect foreign substances in the body (like
viruses and cancer cells). We are trying to learn more about how the body fights these
foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to
detect and kill cancer cells better. We know that in healthy people the immune system
effectively protects against recurrent virus infection. For example, that is why people only
get "mono" (mononucleosis) once under normal circumstances. When the body is infected with
the "mono" virus, the immune system remembers and prevents further infection. We are trying
to use the immune system to prevent cancer relapse. To test this, we will give two vaccines
which have been used to measure these immune responses. Blood samples will be studied from
cancer patients and will be compared to similar samples from normal subjects.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients will receive each vaccine once only consisting of:

Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).

Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).

Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).

Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially
true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus
when it becomes available if there has been no significant change in treatment interventions
or overall health status and it is within 3 months of the KLH vaccine.
</textblock>
</detailed_description>
<overall_status>Terminated</overall_status>
<why_stopped>
Replaced by another study.
</why_stopped>
<start_date>July 2002</start_date>
<completion_date type="Actual">March 2012</completion_date>
<primary_completion_date type="Actual">March 2012</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>To assess whether patients can mediate an appropriate immune response KLH</measure>
<time_frame>Week 4 post vaccination</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Tetanus Response</measure>
<time_frame>Throughout study</time_frame>
</secondary_outcome>
<number_of_groups>3</number_of_groups>
<enrollment type="Actual">112</enrollment>
<condition>Cancer</condition>
<arm_group>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<description>Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).</description>
</arm_group>
<arm_group>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<description>Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).</description>
</arm_group>
<arm_group>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<description>Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.</description>
</arm_group>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Intracel KLH Vaccine</intervention_name>
<description>Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.</description>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<other_name>KLH BCI-ImmuneActivator(TM)</other_name>
<other_name>IntraCel</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Biosyn KLH</intervention_name>
<description>Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.</description>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>Immunocyanin</other_name>
<other_name>IMMUCOTHEL®</other_name>
<other_name>VACMUNE®</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Montanide ISA51</intervention_name>
<description>Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.</description>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>Montanide ISA 51 VG</other_name>
</intervention>
<intervention>
<intervention_type>Biological</intervention_type>
<intervention_name>Tetanus toxoid</intervention_name>
<description>Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.</description>
<arm_group_label>Arm A: Intracel KLH</arm_group_label>
<arm_group_label>Arm B: Biosyn KLH</arm_group_label>
<arm_group_label>Arm C: Biosyn KLH with Montanide ISA51</arm_group_label>
<other_name>PUROGENATED®</other_name>
</intervention>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
analysis of blood samples before and 4 weeks postvaccination
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
- Normal volunteers

- Patients with Cancer (breast, melanoma, hematologic)

- Transplant patients (umbilical cord blood transplant, autologous transplant)

- Patients receiving other cancer vaccines
</textblock>
</study_pop>
<sampling_method>Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion Criteria:

- Patients must have a diagnosis of cancer of any histologic type.

- Patients must have a Karnofsky performance status great or equal to 70%.

- Patients must have an expected survival for at least four months.

- Normal healthy volunteers to serve as control for this study.

- All patients must sign informed consent approved by the Committee on the Use of Human
Subjects at the University of Minnesota

Exclusion Criteria:

- Pregnant or lactating women. Females of child-bearing potential will be asked to take
a pregnancy test before receiving vaccines.

- Serious intercurrent medical illnesses which would interfere with the ability of the
patient to carry out the follow-up monitoring program.

- Immunization should not be administered during the course of any febrile illness or
acute infection.

- Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury
derivative.

- The occurrence of any type of neurologic symptoms to tetanus vaccine in th past.

- Patients with a history of seafood allergy are excluded from receiving KLH.

- Subjects who have had tetanus toxoid within the last 7 years are not eligible for
tetanus vaccine component of this protocol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jeffrey Miller, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
</overall_official>
<location>
<facility>
<name>Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2017</verification_date>
<study_first_submitted>November 3, 1999</study_first_submitted>
<study_first_submitted_qc>November 3, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 4, 1999</study_first_posted>
<last_update_submitted>November 27, 2017</last_update_submitted>
<last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
<last_update_posted type="Actual">November 29, 2017</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Tetanus</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Monatide (IMS 3015)</mesh_term>
<mesh_term>Freund's Adjuvant</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000105
org study id: 2002LS032
secondary id: MT1999-06
nct id: NCT00000105
lead sponsor:
has dmc: Yes
The purpose of this study is to learn how the immune system works in response to vaccines. We
will give the vaccines to subjects who have cancer but have not had treatment, and to
patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines
while they are on treatments which boost the immune system (like the immune stimulating drug
interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting
drugs, we do not yet know if they improve the body's immune system to respond better to a
vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control
subjects to get a good measure of the normal immune response. We will compare the patients
and the healthy volunteers to study how their immune systems respond to the vaccines.
There are several different types of white cells in the blood. We are interested in immune
cells in the blood called T-cells. These T-cells detect foreign substances in the body (like
viruses and cancer cells). We are trying to learn more about how the body fights these
foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to
detect and kill cancer cells better. We know that in healthy people the immune system
effectively protects against recurrent virus infection. For example, that is why people only
get "mono" (mononucleosis) once under normal circumstances. When the body is infected with
the "mono" virus, the immune system remembers and prevents further infection. We are trying
to use the immune system to prevent cancer relapse. To test this, we will give two vaccines
which have been used to measure these immune responses. Blood samples will be studied from
cancer patients and will be compared to similar samples from normal subjects.
Patients will receive each vaccine once only consisting of:
Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).
Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).
Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).
Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially
true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus
when it becomes available if there has been no significant change in treatment interventions
or overall health status and it is within 3 months of the KLH vaccine.
observational model: Case-Control
time perspective: Prospective
measure: To assess whether patients can mediate an appropriate immune response KLH
time frame: Week 4 post vaccination
measure: Tetanus Response
time frame: Throughout study
arm group label: Arm A: Intracel KLH
description: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).
arm group label: Arm B: Biosyn KLH
description: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).
arm group label: Arm C: Biosyn KLH with Montanide ISA51
description: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.
intervention type: Biological
intervention name: Intracel KLH Vaccine
description: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
arm group label: Arm A: Intracel KLH
other name: KLH BCI-ImmuneActivator(TM)
other name: IntraCel
intervention type: Biological
intervention name: Biosyn KLH
description: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
arm group label: Arm B: Biosyn KLH
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: Immunocyanin
other name: IMMUCOTHEL®
other name: VACMUNE®
intervention type: Drug
intervention name: Montanide ISA51
description: Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: Montanide ISA 51 VG
intervention type: Biological
intervention name: Tetanus toxoid
description: Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
arm group label: Arm A: Intracel KLH
arm group label: Arm B: Biosyn KLH
arm group label: Arm C: Biosyn KLH with Montanide ISA51
other name: PUROGENATED®
analysis of blood samples before and 4 weeks postvaccination
study pop:
sampling method: Probability Sample
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Miller, MD
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
facility:
country: United States
responsible party type: Sponsor
mesh term: Tetanus
mesh term: Monatide (IMS 3015)
mesh term: Freund's Adjuvant
|
NCT0000xxxx/NCT00000106.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000106</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR03186-9943</org_study_id>
<secondary_id>M01RR003186</secondary_id>
<nct_id>NCT00000106</nct_id>
</id_info>
<brief_title>41.8 Degree Centigrade Whole Body Hyperthermia for the Treatment of Rheumatoid Diseases</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of
Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II
when patients are heated systemically to 41.8C for 60 minutes. This observation might provide
a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which
there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the
basis for this protocol is the concept that the induction of TNF receptors by WBH may induce
a remission in patients with active rheumatoid arthritis. Beyond clinical response the
biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R
levels and changes in cellular TNF receptors.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Rheumatic Diseases</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Whole body hyperthermia unit</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients are required to meet the criteria of the American College of Rheumatology
(ACR)for rheumatoid arthritis.

- Patients should be in functional class II, or III according to the criteria of the
ACR.

- All candidates must be unsuccessfully treated (lack of efficacy) with at least two of
the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or
injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine.

- Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (<=
10 mg per day), or both are eligible if the dosage has been stable for at least four
weeks before treatment and remained so throughout the study and follow-up period (the
use of narcotics for pain flares is allowed).

- The necessary degree of disease activity at enrollment should be confirmed by a
finding of 10 or more swollen joints, 12 or more tender joints, and one of the
following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm
per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or
morning stiffness for at least 60 minutes.

- Patients must have adequate bone marrow function, adequate liver function, adequate
renal function, calcium and electrolytes.

- Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise
ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit
of the criteria are to rule out organic heart disease.

- Respiratory status: Patients who have FEV1 of >= 60% of predicted, as well as a
maximum voluntary volume (MVV) of >= 60% of predicted, and blood gases with a PO2 of
>= 60 or oxygen saturation of >= 90% are eligible.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>K4/666 CSC 600 Highland Av</name>
<address>
<city>Madison</city>
<state>Wisconsin</state>
<zip>53792</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>November 2000</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Rheumatoid Diseases</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rheumatic Diseases</mesh_term>
<mesh_term>Collagen Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000106
org study id: NCRR-M01RR03186-9943
secondary id: M01RR003186
nct id: NCT00000106
lead sponsor:
Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of
Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II
when patients are heated systemically to 41.8C for 60 minutes. This observation might provide
a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which
there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the
basis for this protocol is the concept that the induction of TNF receptors by WBH may induce
a remission in patients with active rheumatoid arthritis. Beyond clinical response the
biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R
levels and changes in cellular TNF receptors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
intervention type: Device
intervention name: Whole body hyperthermia unit
criteria:
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility:
country: United States
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases
|
NCT0000xxxx/NCT00000107.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000107</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00109-0737</org_study_id>
<secondary_id>M01RR000109</secondary_id>
<nct_id>NCT00000107</nct_id>
</id_info>
<brief_title>Body Water Content in Cyanotic Congenital Heart Disease</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial
natruretic peptide (proANP) which most likely results in chronic dehydration, leading to
reduced oxygen transport to tissues and shortness of breath with activity. The purpose of
this study is to characterize adults with cyanotic congenital heart defects with respect to
their body composition (water and fat-free mass) and resting metabolic rates. The study
consists of several measures of how much body water, fat and lean tissue a subject has, and
measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic
congenital heart disease will be recruited along with healthy noncyanotic control subjects
matched for age, gender, and body weight.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Case-Control</observational_model>
</study_design_info>
<condition>Heart Defects, Congenital</condition>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Resting blood pressure below 140/90
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>17 Years</minimum_age>
<maximum_age>60 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Vermont</name>
<address>
<city>Burlington</city>
<state>Vermont</state>
<zip>05401</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Cyanotic Congenital Heart Disease</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heart Defects, Congenital</mesh_term>
<mesh_term>Congenital Abnormalities</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000107
org study id: NCRR-M01RR00109-0737
secondary id: M01RR000109
nct id: NCT00000107
lead sponsor:
Adults with cyanotic congenital heart disease have elevated levels of plasma proatrial
natruretic peptide (proANP) which most likely results in chronic dehydration, leading to
reduced oxygen transport to tissues and shortness of breath with activity. The purpose of
this study is to characterize adults with cyanotic congenital heart defects with respect to
their body composition (water and fat-free mass) and resting metabolic rates. The study
consists of several measures of how much body water, fat and lean tissue a subject has, and
measures the number of calories the subject's body uses at rest. Adult subjects with cyanotic
congenital heart disease will be recruited along with healthy noncyanotic control subjects
matched for age, gender, and body weight.
observational model: Case-Control
criteria:
gender: All
minimum age: 17 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities
|
NCT0000xxxx/NCT00000108.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000108</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00042-1647</org_study_id>
<secondary_id>M01RR000042</secondary_id>
<nct_id>NCT00000108</nct_id>
</id_info>
<brief_title>Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this research is to find out whether training at different exercise
intensities reduces the risk of developing cardiovascular disease (CVD) to a different
extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
variability of the heart rate and increased dips and swings in blood pressure are risks
factors that predict the chance of developing CVD as are increased levels of clotting protein
fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
(>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
level before you start training and after 15 and 30 weeks of training in the form of walking.
At the present time the effects of exercise intensity on these factors are not well
understood. This study will add to the basic understanding of these issues and allow us to
recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
the risk of developing CVD.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
</study_design_info>
<condition>Cardiovascular Diseases</condition>
<condition>Coronary Disease</condition>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Exercise</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Postmenopausal and preferably on hormone replacement therapy

- In good general health

- Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40

- Exercise less than 20 min/day two days a week
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>3060G Central Campus Recreation Bldg 401 Washtenaw Ave.</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109-2214</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>exercise</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cardiovascular Diseases</mesh_term>
<mesh_term>Coronary Disease</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000108
org study id: NCRR-M01RR00042-1647
secondary id: M01RR000042
nct id: NCT00000108
lead sponsor:
The purpose of this research is to find out whether training at different exercise
intensities reduces the risk of developing cardiovascular disease (CVD) to a different
extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
variability of the heart rate and increased dips and swings in blood pressure are risks
factors that predict the chance of developing CVD as are increased levels of clotting protein
fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
(>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
level before you start training and after 15 and 30 weeks of training in the form of walking.
At the present time the effects of exercise intensity on these factors are not well
understood. This study will add to the basic understanding of these issues and allow us to
recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
the risk of developing CVD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
intervention type: Behavioral
intervention name: Exercise
criteria:
gender: Female
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
mesh term: Cardiovascular Diseases
mesh term: Coronary Disease
|
NCT0000xxxx/NCT00000110.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000110</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00032-0855</org_study_id>
<secondary_id>M01RR000032</secondary_id>
<nct_id>NCT00000110</nct_id>
</id_info>
<brief_title>Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)
to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged
bout of endurance running and, 2) determine the pattern (time course) of IML replenishment
following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of
energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour
training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat
diet in 10 endurance trained athletes who will consume both diets in a randomly assigned
cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance
exercise, and that replenishment of IML will be impaired by an extremely low-fat diet
compared to a moderate-fat diet. Results of this pilot study will be used to apply for
extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary
fat on the health and performance of individuals performing heavy physical training. It is
anticipated that this methodology could also be employed in obesity research to delineate,
longitudinally, the reported cross-sectional relationships among IML stores, insulin
resistance and obesity.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Single</masking>
</study_design_info>
<condition>Obesity</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>magnetic resonance spectroscopy</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>dietary fat</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Healthy volunteers (developmental phase)

- Healthy endurance-trained subjects

- Maximum age for males is 39

- Maximum age for females is 49
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>The University of Alabama at Birmingham Nutrition Sciences Department</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>exercise</keyword>
<keyword>exertion</keyword>
<keyword>physical fitness</keyword>
<keyword>lipids</keyword>
<keyword>nutrition</keyword>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000110
org study id: NCRR-M01RR00032-0855
secondary id: M01RR000032
nct id: NCT00000110
lead sponsor:
The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS)
to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged
bout of endurance running and, 2) determine the pattern (time course) of IML replenishment
following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of
energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour
training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat
diet in 10 endurance trained athletes who will consume both diets in a randomly assigned
cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance
exercise, and that replenishment of IML will be impaired by an extremely low-fat diet
compared to a moderate-fat diet. Results of this pilot study will be used to apply for
extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary
fat on the health and performance of individuals performing heavy physical training. It is
anticipated that this methodology could also be employed in obesity research to delineate,
longitudinally, the reported cross-sectional relationships among IML stores, insulin
resistance and obesity.
primary purpose: Treatment
masking: Single
intervention type: Procedure
intervention name: magnetic resonance spectroscopy
intervention type: Drug
intervention name: dietary fat
criteria:
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility:
country: United States
|
NCT0000xxxx/NCT00000111.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000111</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR00042-1620</org_study_id>
<secondary_id>M01RR000042</secondary_id>
<nct_id>NCT00000111</nct_id>
</id_info>
<brief_title>Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The purpose of this study is to see if we can develop a good graft for oral mucosal tissue
that is like the top of the mouth in a "test tube" that could be used successfully in humans.
We have already done this successfully mice. The next step is to take a small piece of tissue
from a human volunteer and see if we can grow a larger piece of tissue from it outside the
human body and graft it back into the same person successfully. We expect that this technique
will work. It has already been tried in patients with burns of the skin who have had similar
procedures where the skin is grafted back to them. The significance of this research is that
oral tissue taken from the top of the mouth or palate is in limited supply and leaves the
patient with a painful and uncomfortable post surgery experience. If we are successful with
our technique the patient will experience less pain and discomfort from the site that we are
using to grow our tissue outside the body than if we had taken it from the top of the mouth
or palate. In addition, by waiting longer periods to grow the patient's cells we can make
larger pieces of oral tissue than we could have gotten directly from the patient's mouth.
Patients who will participate in this study will need to require a soft tissue graft from the
mouth to an area that needs additional attached or keratinized mucosa. This will most likely
be either in preparation for patients who have or will have dental implants placed. Another
subset of patients are those who need scar tissue released or the vestibule of their mouth
(area that turns from the gums to the lip) released.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<condition>Mouth Diseases</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Oral mucosal graft</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Lack sufficient attached keratinized tissue at recipient surgical site in question
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>September 2000</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>mouth mucosa</keyword>
<keyword>transplants</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mouth Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000111
org study id: NCRR-M01RR00042-1620
secondary id: M01RR000042
nct id: NCT00000111
lead sponsor:
The purpose of this study is to see if we can develop a good graft for oral mucosal tissue
that is like the top of the mouth in a "test tube" that could be used successfully in humans.
We have already done this successfully mice. The next step is to take a small piece of tissue
from a human volunteer and see if we can grow a larger piece of tissue from it outside the
human body and graft it back into the same person successfully. We expect that this technique
will work. It has already been tried in patients with burns of the skin who have had similar
procedures where the skin is grafted back to them. The significance of this research is that
oral tissue taken from the top of the mouth or palate is in limited supply and leaves the
patient with a painful and uncomfortable post surgery experience. If we are successful with
our technique the patient will experience less pain and discomfort from the site that we are
using to grow our tissue outside the body than if we had taken it from the top of the mouth
or palate. In addition, by waiting longer periods to grow the patient's cells we can make
larger pieces of oral tissue than we could have gotten directly from the patient's mouth.
Patients who will participate in this study will need to require a soft tissue graft from the
mouth to an area that needs additional attached or keratinized mucosa. This will most likely
be either in preparation for patients who have or will have dental implants placed. Another
subset of patients are those who need scar tissue released or the vestibule of their mouth
(area that turns from the gums to the lip) released.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
intervention type: Procedure
intervention name: Oral mucosal graft
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
mesh term: Mouth Diseases
|
NCT0000xxxx/NCT00000112.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000112</url>
</required_header>
<id_info>
<org_study_id>NCRR-M01RR06022-0029</org_study_id>
<secondary_id>M01RR006022</secondary_id>
<nct_id>NCT00000112</nct_id>
</id_info>
<brief_title>Prevalence of Carbohydrate Intolerance in Lean and Obese Children</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Center for Research Resources (NCRR)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Center for Research Resources (NCRR)</source>
<brief_summary>
<textblock>
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is
more than just a cosmetic problem, having substantial metabolic consequences. Insulin
resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen
in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance
in lean children with a family history of diabetes and obese children with acanthosis
nigricans with or without a family history of diabetes mellitus will be studied.
</textblock>
</brief_summary>
<overall_status>Unknown status</overall_status>
<last_known_status>Recruiting</last_known_status>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Defined Population</observational_model>
<time_perspective>Other</time_perspective>
</study_design_info>
<condition>Obesity</condition>
<condition>Glucose Intolerance</condition>
<condition>Diabetes</condition>
<condition>Acanthosis Nigricans</condition>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Obesity: BM +/- 95% for age general good health
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>8 Years</minimum_age>
<maximum_age>18 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Sonia Caprio, M.D.</last_name>
<phone>1-203-764-5692</phone>
<email>[email protected]</email>
</overall_contact>
<location>
<facility>
<name>Yale University School of Medicine, Pediatric Endocrinology</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520-8064</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2003</verification_date>
<study_first_submitted>January 18, 2000</study_first_submitted>
<study_first_submitted_qc>January 18, 2000</study_first_submitted_qc>
<study_first_posted type="Estimate">January 19, 2000</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acanthosis Nigricans</mesh_term>
<mesh_term>Glucose Intolerance</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000112
org study id: NCRR-M01RR06022-0029
secondary id: M01RR006022
nct id: NCT00000112
lead sponsor:
The prevalence of obesity in children is reaching epidemic proportions. Excess adiposity is
more than just a cosmetic problem, having substantial metabolic consequences. Insulin
resistance, hyperinsulinemia, impaired glucose tolerance, and frank diabetes are often seen
in obese children. In this study the prevalence of impaired glucose (carbohydrate) tolerance
in lean children with a family history of diabetes and obese children with acanthosis
nigricans with or without a family history of diabetes mellitus will be studied.
observational model: Defined Population
time perspective: Other
criteria:
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sonia Caprio, M.D.
phone: 1-203-764-5692
email: [email protected]
facility:
status: Recruiting
country: United States
mesh term: Acanthosis Nigricans
mesh term: Glucose Intolerance
|
NCT0000xxxx/NCT00000113.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000113</url>
</required_header>
<id_info>
<org_study_id>NEI-9</org_study_id>
<secondary_id>U10EY011756</secondary_id>
<nct_id>NCT00000113</nct_id>
</id_info>
<brief_title>Correction of Myopia Evaluation Trial (COMET)</brief_title>
<official_title>Correction of Myopia Evaluation Trial (COMET)</official_title>
<sponsors>
<lead_sponsor>
<agency>Stony Brook University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Stony Brook University</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of
juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured
by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by
A-scan ultrasonography.

To describe the natural history of juvenile-onset myopia in a group of children receiving
conventional treatment (single vision lenses).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Myopia (nearsightedness) is an important public health problem, which entails substantial
societal and personal costs. It is highly prevalent in our society and even more frequent in
Asian countries; furthermore, its prevalence may be increasing over time. High myopia
contributes to significant loss of vision and blindness. At present, the mechanisms involved
in the etiology of myopia are unclear, and there is no way to prevent the condition. Current
methods of correction require lifelong use of lenses or surgical treatment, which is
expensive and may lead to complications. The rationale for this trial, the Correction of
Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the
link between accommodation and myopia in children and (2) animal models of myopia showing the
important role of the visual environment in eye growth. A contribution of this research is
that blur is a critical component in the development of myopia. The primary aim of COMET, to
evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing
the progression of myopia, follows from this line of reasoning. These lenses should provide
clear visual input over a range of viewing distances without focusing effort by the child.
The comparison of myopia progression in children treated with PALs versus single vision
lenses will allow the quantification of the effect of PALs on myopia progression during the
followup period.

The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs
slow the progression of juvenile-onset myopia as compared with single vision lenses. The
study is a collaborative effort that involves a Study Chair at the New England College of
Optometry; four clinical centers at colleges of optometry in Boston, Birmingham,
Philadelphia, and Houston; and a Coordinating Center at the State University of New York at
Stony Brook.

The sample size goal, 450 children with myopia in both eyes who met specific inclusion and
exclusion criteria, was attained with the enrollment of 469 children in one year. Children
were identified from school screenings, clinic records, and referrals from local
practitioners. Eligible children were randomly assigned to receive progressive addition or
single vision lenses. Participating children are being examined at 6-month intervals
following baseline, for at least 3 years, to measure changes in refractive error and to
update prescriptions, according to a specified protocol. A dilated examination to evaluate
the study outcome measures is performed at the annual study visits. A standardized, common
protocol is used at all centers.

The primary outcome of the study is progression of myopia, defined as the magnitude of the
change relative to baseline in spherical equivalent refraction, determined by cycloplegic
autorefraction. The secondary outcome of the study is axial length measured by A-scan
ultrasonography.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1997</start_date>
<completion_date type="Actual">September 2013</completion_date>
<primary_completion_date type="Actual">October 2001</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression of myopia, determined by cycloplegic autorefraction</measure>
</primary_outcome>
<secondary_outcome>
<measure>Axial length measured by A-scan ultrasonography</measure>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">469</enrollment>
<condition>Myopia</condition>
<arm_group>
<arm_group_label>Progressive Addition Lenses (PALs)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Single Vision Lenses</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Progressive Addition Lenses</intervention_name>
<description>Varilux comfort with +2.00 addition</description>
<arm_group_label>Progressive Addition Lenses (PALs)</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>single vision lenses</intervention_name>
<arm_group_label>Single Vision Lenses</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Children between the ages of 6 and 12 years with myopia in both eyes (defined as spherical
equivalent between -1.25 D and -4.50 D in each eye as measured by cycloplegic
autorefraction), astigmatism less than or equal to 1.50 D, and no anisometropia (defined as
a difference in spherical equivalent between the two eyes greater than 1.0 D) are eligible
for inclusion. Exclusion criteria include visual acuity greater than 20/25, strabismus, use
of contact lenses, birth weight less than 1,250 grams, use of bifocal or progressive
addition lenses, or any conditions precluding adherence to the protocol.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>12 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jane Gwiazda, PhD</last_name>
<role>Study Chair</role>
<affiliation>New England College of Optometry</affiliation>
</overall_official>
<overall_official>
<last_name>Leslie Hyman, PhD</last_name>
<role>Study Director</role>
<affiliation>Stony Brook Medicine</affiliation>
</overall_official>
<location>
<facility>
<name>University of Alabama-Birmingham, School of Optometry</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294-0010</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New England College of Optometry</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pennsylvania College of Optometry</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19141-3399</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Houston, College of Optometry</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77204-6052</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/health/clinicalstudies/</url>
<description>NEI Clinical Studies Database</description>
</link>
<results_reference>
<citation>Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.</citation>
<PMID>12657584</PMID>
</results_reference>
<results_reference>
<citation>Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.</citation>
<PMID>15223788</PMID>
</results_reference>
<results_reference>
<citation>Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.</citation>
<PMID>16009841</PMID>
</results_reference>
<verification_date>April 2016</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>April 14, 2016</last_update_submitted>
<last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">April 15, 2016</last_update_posted>
<keyword>myopia</keyword>
<keyword>nearsightedness</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myopia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000113
org study id: NEI-9
secondary id: U10EY011756
nct id: NCT00000113
lead sponsor:
collaborator:
has dmc: Yes
To evaluate whether progressive addition lenses (PALs) slow the rate of progression of
juvenile-onset myopia (nearsightedness) when compared with single vision lenses, as measured
by cycloplegic autorefraction. An additional outcome measure is axial length, as measured by
A-scan ultrasonography.
To describe the natural history of juvenile-onset myopia in a group of children receiving
conventional treatment (single vision lenses).
Myopia (nearsightedness) is an important public health problem, which entails substantial
societal and personal costs. It is highly prevalent in our society and even more frequent in
Asian countries; furthermore, its prevalence may be increasing over time. High myopia
contributes to significant loss of vision and blindness. At present, the mechanisms involved
in the etiology of myopia are unclear, and there is no way to prevent the condition. Current
methods of correction require lifelong use of lenses or surgical treatment, which is
expensive and may lead to complications. The rationale for this trial, the Correction of
Myopia Evaluation Trial (COMET), arises from the convergence of research involving (1) the
link between accommodation and myopia in children and (2) animal models of myopia showing the
important role of the visual environment in eye growth. A contribution of this research is
that blur is a critical component in the development of myopia. The primary aim of COMET, to
evaluate the efficacy of progressive addition lenses, a noninvasive intervention, in slowing
the progression of myopia, follows from this line of reasoning. These lenses should provide
clear visual input over a range of viewing distances without focusing effort by the child.
The comparison of myopia progression in children treated with PALs versus single vision
lenses will allow the quantification of the effect of PALs on myopia progression during the
followup period.
The COMET is a multicenter, randomized, double-masked clinical trial to evaluate whether PALs
slow the progression of juvenile-onset myopia as compared with single vision lenses. The
study is a collaborative effort that involves a Study Chair at the New England College of
Optometry; four clinical centers at colleges of optometry in Boston, Birmingham,
Philadelphia, and Houston; and a Coordinating Center at the State University of New York at
Stony Brook.
The sample size goal, 450 children with myopia in both eyes who met specific inclusion and
exclusion criteria, was attained with the enrollment of 469 children in one year. Children
were identified from school screenings, clinic records, and referrals from local
practitioners. Eligible children were randomly assigned to receive progressive addition or
single vision lenses. Participating children are being examined at 6-month intervals
following baseline, for at least 3 years, to measure changes in refractive error and to
update prescriptions, according to a specified protocol. A dilated examination to evaluate
the study outcome measures is performed at the annual study visits. A standardized, common
protocol is used at all centers.
The primary outcome of the study is progression of myopia, defined as the magnitude of the
change relative to baseline in spherical equivalent refraction, determined by cycloplegic
autorefraction. The secondary outcome of the study is axial length measured by A-scan
ultrasonography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Progression of myopia, determined by cycloplegic autorefraction
measure: Axial length measured by A-scan ultrasonography
arm group label: Progressive Addition Lenses (PALs)
arm group type: Experimental
arm group label: Single Vision Lenses
arm group type: Active Comparator
intervention type: Other
intervention name: Progressive Addition Lenses
description: Varilux comfort with +2.00 addition
arm group label: Progressive Addition Lenses (PALs)
intervention type: Other
intervention name: single vision lenses
arm group label: Single Vision Lenses
criteria:
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Jane Gwiazda, PhD
role: Study Chair
affiliation: New England College of Optometry
last name: Leslie Hyman, PhD
role: Study Director
affiliation: Stony Brook Medicine
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/health/clinicalstudies/
description: NEI Clinical Studies Database
citation: Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.
PMID: 12657584
citation: Gwiazda JE, Hyman L, Norton TT, Hussein ME, Marsh-Tootle W, Manny R, Wang Y, Everett D; COMET Grouup. Accommodation and related risk factors associated with myopia progression and their interaction with treatment in COMET children. Invest Ophthalmol Vis Sci. 2004 Jul;45(7):2143-51. doi: 10.1167/iovs.03-1306.
PMID: 15223788
citation: Hyman L, Gwiazda J, Hussein M, Norton TT, Wang Y, Marsh-Tootle W, Everett D. Relationship of age, sex, and ethnicity with myopia progression and axial elongation in the correction of myopia evaluation trial. Arch Ophthalmol. 2005 Jul;123(7):977-87. doi: 10.1001/archopht.123.7.977.
PMID: 16009841
mesh term: Myopia
|
NCT0000xxxx/NCT00000114.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000114</url>
</required_header>
<id_info>
<org_study_id>NEI-10</org_study_id>
<nct_id>NCT00000114</nct_id>
</id_info>
<brief_title>Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the
course of retinitis pigmentosa.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and
lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to
progressive loss of both rod and cone function. Most patients have reductions in central
vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record
retinal responses from most patients with remaining vision and thereby monitor objectively
the course of their disease.

While the natural course of retinal degeneration in the common forms of RP was being studied,
it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with
both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG
amplitude over a 2-year period. These preliminary findings, as well as the known roles of
vitamins A and E in maintaining normal photoreceptor function and structure, prompted this
randomized, controlled trial to determine whether these vitamins alone or in combination
would halt or slow the progression of the common forms of RP.

This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and
duration of 4 to 6 years. Patients were assigned to one of four treatment groups:

15,000 IU/day vitamin A

15,000 IU/day vitamin A + 400 IU/day vitamin E

trace amounts of both vitamins A and E

400 IU/day of vitamin E

The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and
visual acuity were measured annually.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1984</start_date>
<completion_date type="Actual">June 1987</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Retinitis Pigmentosa</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin E</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin A</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and nonpregnant women between ages 18 and 49 years with common forms of RP were
included. All eligible patients had retinal arteriolar attenuation, elevated dark
adaptation thresholds, and reduced ERGs. Patients had best corrected Snellen visual acuity
of 20/100 or better, central visual field diameter on the Goldman perimeter with V4 e white
test light of 8 degrees or greater, and ERG amplitude of 2.5 or greater in response to
0.5-Hz white light or of 0.12 ultraviolet light or greater in response to 30-Hz white
flickering light in at least one eye. In addition, patients had normal fasting serum
retinol and serum liver function profile and weight above the lower fifth percentile for
age, sex, and height. All patients had a total estimated pre-trial intake of vitamins A and
E from diet plus pills not greater than 11,500 IU/day and 40 IU/day, respectively.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-rp.asp</url>
<description>Clinical Alert-Information for Doctors Who Follow Patients with Retinitis Pigmentosa</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/rppressrelease.asp</url>
<description>NEI Press Release-Treatment for Retinitis Pigmentosa Reported</description>
</link>
<reference>
<citation>Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.</citation>
<PMID>8512476</PMID>
</reference>
<reference>
<citation>Sandberg MA, Weigel-DiFranco C, Rosner B, Berson EL. The relationship between visual field size and electroretinogram amplitude in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1996 Jul;37(8):1693-8.</citation>
<PMID>8675413</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>retinitis pigmentosa</keyword>
<keyword>vitamin supplements</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinitis</mesh_term>
<mesh_term>Retinitis Pigmentosa</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamins</mesh_term>
<mesh_term>Vitamin E</mesh_term>
<mesh_term>Vitamin A</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000114
org study id: NEI-10
nct id: NCT00000114
lead sponsor:
To determine whether supplements of vitamin A or vitamin E alone or in combination affect the
course of retinitis pigmentosa.
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and
lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to
progressive loss of both rod and cone function. Most patients have reductions in central
vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record
retinal responses from most patients with remaining vision and thereby monitor objectively
the course of their disease.
While the natural course of retinal degeneration in the common forms of RP was being studied,
it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with
both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG
amplitude over a 2-year period. These preliminary findings, as well as the known roles of
vitamins A and E in maintaining normal photoreceptor function and structure, prompted this
randomized, controlled trial to determine whether these vitamins alone or in combination
would halt or slow the progression of the common forms of RP.
This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and
duration of 4 to 6 years. Patients were assigned to one of four treatment groups:
15,000 IU/day vitamin A
15,000 IU/day vitamin A + 400 IU/day vitamin E
trace amounts of both vitamins A and E
400 IU/day of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and
visual acuity were measured annually.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Vitamin E
intervention type: Drug
intervention name: Vitamin A
criteria:
gender: All
minimum age: 18 Years
maximum age: 49 Years
url: http://www.nei.nih.gov/news/clinicalalerts/alert-rp.asp
description: Clinical Alert-Information for Doctors Who Follow Patients with Retinitis Pigmentosa
url: http://www.nei.nih.gov/news/pressreleases/rppressrelease.asp
description: NEI Press Release-Treatment for Retinitis Pigmentosa Reported
citation: Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.
PMID: 8512476
citation: Sandberg MA, Weigel-DiFranco C, Rosner B, Berson EL. The relationship between visual field size and electroretinogram amplitude in retinitis pigmentosa. Invest Ophthalmol Vis Sci. 1996 Jul;37(8):1693-8.
PMID: 8675413
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Vitamin A
|
NCT0000xxxx/NCT00000115.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000115</url>
</required_header>
<id_info>
<org_study_id>NEI-11</org_study_id>
<nct_id>NCT00000115</nct_id>
</id_info>
<brief_title>Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular
edema.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual
impairment in the United States. Uveitis may lead to many sight-threatening conditions,
including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema.
Reduction of swelling or edema within the retina depends on the movement of fluid from the
retina through the choroid. A number of studies indicate that this process requires active
transport of fluid ions by the retinal pigment epithelium and may involve the carbonic
anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the
use of immunosuppressive or anti-inflammatory agents. However, many patients are either
resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a
carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma
patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.

Because the course of ocular inflammatory disease can be variable, a double-masked,
randomized, crossover trial was designed to test the efficacy of acetazolamide compared with
a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult
patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours
for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose
based on body weight. Following a 4-week period, during which no medication was given,
patients then received a 4-week course of the opposite medication. Primary end points
included reduction in cystoid macular edema (graded on fluorescein angiography) and
improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy
Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable.
Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory
examinations.

A total of 40 patients were recruited for the study. Patients were seen at the beginning of
the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the
study.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1990</start_date>
<completion_date type="Actual">June 1994</completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Macular Edema, Cystoid</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Acetazolamide</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Males and females 8 years of age or older and weighing at least 35 kg (77 lb) were eligible
for the study. Patients had to have a best corrected visual acuity of 20/40 or worse in at
least one eye with cystoid macular edema demonstrable on fluorescein angiography.

Patients were allowed to receive systemic therapy for their uveitis. Exclusion criteria
included current use of acetazolamide as part of a therapeutic regimen; a history of
hypersensitivity reactions to acetazolamide, sulfonamides, or angiography dye; unclear
ocular media that would obscure fluorescein angiography; macular subretinal
neovascularization or a macular hole; or inability to take acetazolamide for medical
reasons.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>8 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<reference>
<citation>Whitcup SM, Csaky KG, Podgor MJ, Chew EY, Perry CH, Nussenblatt RB. A randomized, masked, cross-over trial of acetazolamide for cystoid macular edema in patients with uveitis. Ophthalmology. 1996 Jul;103(7):1054-62; discussion 1062-3. doi: 10.1016/s0161-6420(96)30567-8.</citation>
<PMID>8684794</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Edema</mesh_term>
<mesh_term>Edema</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acetazolamide</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000115
org study id: NEI-11
nct id: NCT00000115
lead sponsor:
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular
edema.
Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual
impairment in the United States. Uveitis may lead to many sight-threatening conditions,
including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema.
Reduction of swelling or edema within the retina depends on the movement of fluid from the
retina through the choroid. A number of studies indicate that this process requires active
transport of fluid ions by the retinal pigment epithelium and may involve the carbonic
anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the
use of immunosuppressive or anti-inflammatory agents. However, many patients are either
resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a
carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma
patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.
Because the course of ocular inflammatory disease can be variable, a double-masked,
randomized, crossover trial was designed to test the efficacy of acetazolamide compared with
a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult
patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours
for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose
based on body weight. Following a 4-week period, during which no medication was given,
patients then received a 4-week course of the opposite medication. Primary end points
included reduction in cystoid macular edema (graded on fluorescein angiography) and
improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy
Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable.
Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory
examinations.
A total of 40 patients were recruited for the study. Patients were seen at the beginning of
the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the
study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Acetazolamide
criteria:
gender: All
minimum age: 8 Years
maximum age: N/A
citation: Whitcup SM, Csaky KG, Podgor MJ, Chew EY, Perry CH, Nussenblatt RB. A randomized, masked, cross-over trial of acetazolamide for cystoid macular edema in patients with uveitis. Ophthalmology. 1996 Jul;103(7):1054-62; discussion 1062-3. doi: 10.1016/s0161-6420(96)30567-8.
PMID: 8684794
mesh term: Macular Edema
mesh term: Edema
mesh term: Acetazolamide
|
NCT0000xxxx/NCT00000116.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000116</url>
</required_header>
<id_info>
<org_study_id>NEI-12</org_study_id>
<nct_id>NCT00000116</nct_id>
</id_info>
<brief_title>Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A</brief_title>
<official_title>Clinical Trial of Docosahexaenoic Acid (DHA) in Patients With Retinitis Pigmentosa Receiving Vitamin A Treatment</official_title>
<sponsors>
<lead_sponsor>
<agency>Carol Weigel DiFranco</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this trial is to determine whether a nutritional supplement in addition to
vitamin A will slow the course of retinitis pigmentosa.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of approximately 1 in 4,000. Patients typically report night blindness and
difficulty with midperipheral visual field in adolescence. As the condition progresses, they
lose far peripheral visual field. Most patients have reductions in central vision by age 50
to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on
average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
the effects of vitamin A on RP, it became apparent that another substance in the diet could
be affecting the course of the disease. This prompted the present randomized, controlled
trial.

This study is a randomized, controlled, double-masked trial with a planned duration of 5
years. Patients with the common forms of RP are assigned to either a test or a control group.
All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of
docosahexaenoic acid or control capsules. Participants will not know the contents of the
supplement or the group to which they have been assigned until the end of the trial. The main
outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In
addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured
annually.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">May 1996</start_date>
<completion_date type="Actual">September 2002</completion_date>
<primary_completion_date type="Actual">September 2002</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
<masking_description>In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment.</masking_description>
</study_design_info>
<primary_outcome>
<measure>Change in Humphrey Field Analyzer (HFA) total point score 30-2 program</measure>
<time_frame>Annual percent change per year at each of 4 years of followup</time_frame>
<description>Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field</description>
</primary_outcome>
<secondary_outcome>
<measure>Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined</measure>
<time_frame>Annual percent change per year at each of four years of followup</time_frame>
<description>Sum of points in decibels of total points seen in 30-2 and 30/60-2 programs combined- Higher scores = better vision/ larger visual field</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in 30Hz Electroretinogram ( ERG) amplitude</measure>
<time_frame>Annual percent change per year at each of four years of followup</time_frame>
<description>Value in microvolts of response to 30hz ERG. Higher values = greater visual function</description>
</secondary_outcome>
<secondary_outcome>
<measure>Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity</measure>
<time_frame>Change in number of letters read per year at each of four years of followup.</time_frame>
<description>Number of letters read per year. More letters read = better visual acuity</description>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">221</enrollment>
<condition>Retinitis Pigmentosa</condition>
<arm_group>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate</description>
</arm_group>
<arm_group>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate</description>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Vitamin A</intervention_name>
<description>15000 IU/d as retinyl palmitate</description>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Docosahexaenoic acid</intervention_name>
<description>1200 mg/d</description>
<arm_group_label>Docosahexaenoic acid + Vitamin A</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Control fatty acid</intervention_name>
<arm_group_label>Control fatty acid + Vitamin A</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

Ocular Criteria:

Retinitis Pigmentosa, typical (non-syndromic) forms Best corrected visual acuity Greater
than or equal to (GE )20/100 HFA 30-2 total point score GE 250 dB (decibels) 30 (Hertz) Hz
ERG cone amplitude GE 0.68 microvolts

Dietary Criteria:

Dark fish intake Less than or equal to (LE) five servings per week Dietary omega-3 fatty
acid intake LE 0.41 g/d Preformed Vitamin A intake in diet and supplements LE 10,000 IU/d
Supplement intake LE 5000 IU/d of Vitamin A and LE 30 IU/d Vitamin E Consumption LE 3
alcoholic beverages per day

Medical and other criteria:

Body Mass Index Less than (LT )40 and weight GE 5th percentile for age, sex, and height
Serum retinol level LE 100 mg/dl and serum retinyl ester levels LE 380 nm/L Serum
cholesterol level LT 300 mg/dL and serum triglyceride levels LT 400 mg/dL Agree not to know
study capsule content

Exclusion criteria:

Ocular criteria:

No confounding ocular disease

Dietary criteria:

No intake of cod liver oil or omega-3 capsules

Medical and other criteria:

Not pregnant or planning to become pregnant No clinically significant abnormal result on
Complete Blood Count or serum liver function profile No other disease which might affect
absorption or metabolism of DHA or Vitamin A
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>55 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Eliot Berson (Deceased), MD</last_name>
<role>Principal Investigator</role>
<affiliation>Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School</affiliation>
</overall_official>
<location>
<facility>
<name>Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.</citation>
<PMID>8512476</PMID>
</reference>
<results_reference>
<citation>Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.</citation>
<PMID>15364708</PMID>
</results_reference>
<results_reference>
<citation>Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306.</citation>
<PMID>15364709</PMID>
</results_reference>
<verification_date>February 2023</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>February 22, 2023</last_update_submitted>
<last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
<last_update_posted type="Actual">March 8, 2023</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor-Investigator</responsible_party_type>
<investigator_affiliation>National Eye Institute (NEI)</investigator_affiliation>
<investigator_full_name>Carol Weigel DiFranco</investigator_full_name>
<investigator_title>coauthor/program manager</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinitis</mesh_term>
<mesh_term>Retinitis Pigmentosa</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamin A</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000116
org study id: NEI-12
nct id: NCT00000116
lead sponsor:
has dmc: Yes
The purpose of this trial is to determine whether a nutritional supplement in addition to
vitamin A will slow the course of retinitis pigmentosa.
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
prevalence of approximately 1 in 4,000. Patients typically report night blindness and
difficulty with midperipheral visual field in adolescence. As the condition progresses, they
lose far peripheral visual field. Most patients have reductions in central vision by age 50
to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on
average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
the effects of vitamin A on RP, it became apparent that another substance in the diet could
be affecting the course of the disease. This prompted the present randomized, controlled
trial.
This study is a randomized, controlled, double-masked trial with a planned duration of 5
years. Patients with the common forms of RP are assigned to either a test or a control group.
All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of
docosahexaenoic acid or control capsules. Participants will not know the contents of the
supplement or the group to which they have been assigned until the end of the trial. The main
outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In
addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured
annually.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: In this trial neither the participants, nor the clinicians, nor the investigators were aware of treatment group assignment.
measure: Change in Humphrey Field Analyzer (HFA) total point score 30-2 program
time frame: Annual percent change per year at each of 4 years of followup
description: Sum of points in Decibels of total points seen in 30-2 program. Higher scores = better vision/larger visual field
measure: Change in Humphrey Field Analyzer (HFA) total point score 30 -2 plus 30/60-2 programs combined
time frame: Annual percent change per year at each of four years of followup
description: Sum of points in decibels of total points seen in 30-2 and 30/60-2 programs combined- Higher scores = better vision/ larger visual field
measure: Change in 30Hz Electroretinogram ( ERG) amplitude
time frame: Annual percent change per year at each of four years of followup
description: Value in microvolts of response to 30hz ERG. Higher values = greater visual function
measure: Change in Early Treatment of Diabetic Retinopathy(EDTRS) Visual Acuity
time frame: Change in number of letters read per year at each of four years of followup.
description: Number of letters read per year. More letters read = better visual acuity
arm group label: Docosahexaenoic acid + Vitamin A
arm group type: Experimental
description: Participants randomized to this arm received 1200 mg/d docosahexaenoic acid and 15000 IU/d Vitamin A as retinyl palmitate
arm group label: Control fatty acid + Vitamin A
arm group type: Placebo Comparator
description: Patients randomized to this arm received 500 mg/d of fatty acid with no docosahexaenoic acid and 15000 IU/ Vitamin A as retinyl palmitate
intervention type: Dietary Supplement
intervention name: Vitamin A
description: 15000 IU/d as retinyl palmitate
arm group label: Control fatty acid + Vitamin A
arm group label: Docosahexaenoic acid + Vitamin A
intervention type: Dietary Supplement
intervention name: Docosahexaenoic acid
description: 1200 mg/d
arm group label: Docosahexaenoic acid + Vitamin A
intervention type: Dietary Supplement
intervention name: Control fatty acid
arm group label: Control fatty acid + Vitamin A
criteria:
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eliot Berson (Deceased), MD
role: Principal Investigator
affiliation: Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School
facility:
country: United States
citation: Berson EL, Rosner B, Sandberg MA, Hayes KC, Nicholson BW, Weigel-DiFranco C, Willett W. A randomized trial of vitamin A and vitamin E supplementation for retinitis pigmentosa. Arch Ophthalmol. 1993 Jun;111(6):761-72. doi: 10.1001/archopht.1993.01090060049022.
PMID: 8512476
citation: Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.
PMID: 15364708
citation: Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14. doi: 10.1001/archopht.122.9.1306.
PMID: 15364709
responsible party type: Sponsor-Investigator
investigator affiliation: National Eye Institute (NEI)
investigator full name: Carol Weigel DiFranco
investigator title: coauthor/program manager
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
mesh term: Vitamin A
|
NCT0000xxxx/NCT00000117.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000117</url>
</required_header>
<id_info>
<org_study_id>NEI-13</org_study_id>
<nct_id>NCT00000117</nct_id>
</id_info>
<brief_title>Intravenous Immunoglobulin Therapy in Optic Neuritis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than
placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).

To determine the time course of recovery following IVIg administration. If the reports of
IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can
be confirmed, this would provide indirect evidence that IVIg may promote central nervous
system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in
young adults. Characteristically, patients present with central visual loss that peaks within
a few days and is often associated with eye pain. Visual loss may be complete. Spontaneous
recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in
most patients. Although clinical improvement is the rule, not all patients recover fully, and
many are left with residual symptoms. Although there are limited pathological studies in
inflammatory ON, the pathological changes are thought to be virtually identical with those
seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with
axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages
around the inflammatory demyelination lesion; various degrees of remyelination; and, later,
oligodendrocyte loss, axonal loss, and gliosis.

Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin
sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are
often seen prominently at the edge of demyelinated plaques. A recent series of studies has
shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration
and remyelination. These immature oligodendrocytes express a series of developmentally
restricted antigens. This finding has been interpreted to suggest that the cells that
repopulate the acute plaque and that affect remyelination are newly generated and not
residual, mature oligodendrocytes. These observations support the possibility that factors
that promote remyelination could be used to improve clinical recovery in ON and MS.

Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal
cord antigens and purified polyclonal mouse IgG administered systemically promote extensive
remyelination in SJL mice chronically infected with Theiler's virus. In addition, tissue
culture studies suggest that IgG directed against CNS components may promote oligodendroglial
proliferation and differentiation. Thus, experimental evidence exists for the concept that
immunoglobulins may stimulate the proliferation and differentiation of oligodendrocytes. It
is possible that myelin components on the surface of oligodendrocytes could function as
receptors or components of receptors. Antibodies could mimic endogenous ligands, thereby
inducing the proliferation or differentiation of these cells.

In a preliminary, open-label pilot study of patients with chronic, steroid-unresponsive ON,
Drs. van Engelen, Hommes, and colleagues suggested that improvement in visual recovery could
be seen following IgG treatment in patients with chronic, stable ON. These encouraging but
preliminary basic and clinical studies have prompted us to design a double-blind and
placebo-controlled clinical trial of IVIg in patients with recently acquired but apparently
permanent muscle paralysis from MS (NS31506) and to develop this NEI-funded ON study
(U10EY1096301).

In this randomized, placebo-controlled, double-blind clinical trial, 60 patients were
assigned to receive either IVIg or a placebo over a period of 3 months. In order to be
eligible, patients who meet the inclusion criteria needed to have a stable loss of visual
function (unchanged between the pre-enrollment screening visit and the enrollment visit). All
patients wre re-examined at 3, 6, 9, and 12 months, with the primary outcome being the impact
of treatment on visual acuity at 6 months as determined by measurements on a retroilluminated
Early Treatment Diabetic Retinopathy Study chart at 4 meters.

One group of patients received 0.4 g/kg Gammimmune N intravenously daily for 5 days, and
thereafter once a month for 3 months (total: eight infusions). The other group of patients
received infusions of 0.1 percent human serum albumin in 10 percent maltose (placebo)
according to the identical protocol used for Gammimmune N.

The primary outcome measure was improvement in Logmar visual acuity by an average of 0.2 at 6
months. The secondary outcome measures included change in visual acuity at 3, 9, and 12
months, as determined on a retroilluminated ETDRS chart at 4 meters; change in visual fields
at 6 and 12 months; change in visual evoked responses at 3, 6, and 12 months; and change in
neurological examination (EDSS, FS, AI) at 3, 6, 9, and 12 months.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>August 1995</start_date>
<completion_date type="Actual">December 1997</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Optic Neuritis</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Immunoglobulin</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
To be eligible, patients must have a history of one or more episodes of previous
demyelinating optic neuritis occurring in the setting of classic, adult-onset definite MS
(clinically definite or laboratory-supported definite MS, or cranial MRI changes consistent
with MS). In most cases, onset of MS will have occurred between the ages of 18 and 45.
Patients must be younger than 50 years and must have apparently irreversible loss of visual
acuity that meets the following criteria:

Visual acuity must be worse than 20/40 for at least 6 months. Patients must be able to read
at least one letter on the 1-meter eye chart. Patients with no light perception or hand
movement vision only are not eligible.

The above level of visual dysfunction must be observed on at least two serial examinations
(separated by at least 1 month) in the Department of Ophthalmology at the Mayo Clinic.

Optic disc pallor must be present.

Patients must have impairment in the affected eye(s) on perimetry consistent with optic
nerve dysfunction and must have a visual field mean deviation of less than -4.00.

Patients must not have received ACTH or corticosteroids within the preceding 2 months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>50 Years</maximum_age>
</eligibility>
<location>
<facility>
<name>Mayo Clinic, Department of Neurology</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Neuritis</mesh_term>
<mesh_term>Optic Neuritis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Immunoglobulins</mesh_term>
<mesh_term>Immunoglobulins, Intravenous</mesh_term>
<mesh_term>Antibodies</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000117
org study id: NEI-13
nct id: NCT00000117
lead sponsor:
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than
placebo in restoring lost visual function (visual acuity) in optic neuritis (ON).
To determine the time course of recovery following IVIg administration. If the reports of
IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can
be confirmed, this would provide indirect evidence that IVIg may promote central nervous
system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
Optic neuritis is the leading cause of transient, spontaneous, reversible visual loss in
young adults. Characteristically, patients present with central visual loss that peaks within
a few days and is often associated with eye pain. Visual loss may be complete. Spontaneous
recovery usually begins within 4 weeks, and marked recovery occurs within 1 to 3 months in
most patients. Although clinical improvement is the rule, not all patients recover fully, and
many are left with residual symptoms. Although there are limited pathological studies in
inflammatory ON, the pathological changes are thought to be virtually identical with those
seen in MS, with disruption of the blood-nerve (brain) barrier; primary demyelination with
axonal sparing; variable degrees of lymphocytic infiltration; an abundance of macrophages
around the inflammatory demyelination lesion; various degrees of remyelination; and, later,
oligodendrocyte loss, axonal loss, and gliosis.
Remyelination by oligodendrocytes occurs early in the MS lesion, as documented by myelin
sheaths that are abnormally thin relative to axon diameter. These thin myelin sheaths are
often seen prominently at the edge of demyelinated plaques. A recent series of studies has
shown that within weeks of the initial event, there is extensive oligodendrocyte regeneration
and remyelination. These immature oligodendrocytes express a series of developmentally
restricted antigens. This finding has been interpreted to suggest that the cells that
repopulate the acute plaque and that affect remyelination are newly generated and not
residual, mature oligodendrocytes. These observations support the possibility that factors
that promote remyelination could be used to improve clinical recovery in ON and MS.
Work at the Mayo Clinic, has shown that both immunoglobulin G (IgG) directed against spinal
cord antigens and purified polyclonal mouse IgG administered systemically promote extensive
remyelination in SJL mice chronically infected with Theiler's virus. In addition, tissue
culture studies suggest that IgG directed against CNS components may promote oligodendroglial
proliferation and differentiation. Thus, experimental evidence exists for the concept that
immunoglobulins may stimulate the proliferation and differentiation of oligodendrocytes. It
is possible that myelin components on the surface of oligodendrocytes could function as
receptors or components of receptors. Antibodies could mimic endogenous ligands, thereby
inducing the proliferation or differentiation of these cells.
In a preliminary, open-label pilot study of patients with chronic, steroid-unresponsive ON,
Drs. van Engelen, Hommes, and colleagues suggested that improvement in visual recovery could
be seen following IgG treatment in patients with chronic, stable ON. These encouraging but
preliminary basic and clinical studies have prompted us to design a double-blind and
placebo-controlled clinical trial of IVIg in patients with recently acquired but apparently
permanent muscle paralysis from MS (NS31506) and to develop this NEI-funded ON study
(U10EY1096301).
In this randomized, placebo-controlled, double-blind clinical trial, 60 patients were
assigned to receive either IVIg or a placebo over a period of 3 months. In order to be
eligible, patients who meet the inclusion criteria needed to have a stable loss of visual
function (unchanged between the pre-enrollment screening visit and the enrollment visit). All
patients wre re-examined at 3, 6, 9, and 12 months, with the primary outcome being the impact
of treatment on visual acuity at 6 months as determined by measurements on a retroilluminated
Early Treatment Diabetic Retinopathy Study chart at 4 meters.
One group of patients received 0.4 g/kg Gammimmune N intravenously daily for 5 days, and
thereafter once a month for 3 months (total: eight infusions). The other group of patients
received infusions of 0.1 percent human serum albumin in 10 percent maltose (placebo)
according to the identical protocol used for Gammimmune N.
The primary outcome measure was improvement in Logmar visual acuity by an average of 0.2 at 6
months. The secondary outcome measures included change in visual acuity at 3, 9, and 12
months, as determined on a retroilluminated ETDRS chart at 4 meters; change in visual fields
at 6 and 12 months; change in visual evoked responses at 3, 6, and 12 months; and change in
neurological examination (EDSS, FS, AI) at 3, 6, 9, and 12 months.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Immunoglobulin
criteria:
gender: All
minimum age: N/A
maximum age: 50 Years
facility:
facility:
country: United States
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
|
NCT0000xxxx/NCT00000118.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000118</url>
</required_header>
<id_info>
<org_study_id>NEI-14</org_study_id>
<nct_id>NCT00000118</nct_id>
</id_info>
<brief_title>Ganciclovir Implant Study for Cytomegalovirus Retinitis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system
for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired
immunodeficiency syndrome (AIDS).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of
visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that
have been approved by the U.S. Food and Drug Administration for the treatment of CMV
retinitis. The therapeutic regimen for each drug consists of a 2-week induction period
followed by daily maintenance intravenous infusions. Unfortunately, CMV retinitis usually
progresses despite daily maintenance therapy, and both drugs are associated with significant
systemic toxicity that often limits their therapeutic usefulness. As an alternative to
intravenous administration, direct intravitreal injections of ganciclovir have been studied
and have been shown to be effective in delaying the progression of CMV retinitis. The short
half-life of the drug, however, necessitates one to two intraocular injections a week to
maintain therapeutic levels. Widespread adoption of this technique has been limited because
of the logistical difficulties and inherent risks associated with numerous intravitreal
injections.

A drug delivery system capable of continuous delivery of ganciclovir into the vitreous cavity
has been developed. The device consists of a 6-mg pellet of ganciclovir that is coated with a
series of polymers with variable permeability to ganciclovir. The device is surgically
implanted through the pars plana.

Thirty eyes of 26 patients with unilateral non-sight-threatening CMV retinitis were randomly
assigned to one of two groups: (1) immediate therapy with a device designed to release
ganciclovir into the vitreous cavity a over approximately a 4-month period or (2) deferred
treatment. In patients with bilateral non-sight-threatening CMV retinitis, one eye was
randomly assigned to receive a ganciclovir implant with the other eye assigned to deferred
treatment. (Note: The original trial design included a third randomized arm using a 2 ug/hour
device. This arm was dropped for logistical reasons after enrolling two patients.)

Patients assigned to immediate treatment underwent surgery to implant the ganciclovir device
within 48 hours of enrollment and baseline photographs. Postoperatively, patients were
evaluated the next day, weekly for 2 weeks, and then every 2 weeks until progression of CMV
retinitis occurred. At each examination, in both eyes, visual acuity with current correction
and best correction was determined using Early Treatment Diabetic Retinopathy Study eye
charts; intraocular pressure was determined; evidence of inflammation or cataract was
evaluated; and all retinal findings were documented. Any adverse event considered even
possibly related to the device or to the implantation procedure was documented. Standardized
nine-field fundus photographs were taken at each 2-week visit. The ganciclovir implant was
exchanged at 32 weeks or earlier if progression of CMV retinitis occurred.

The primary end point was time to CMV retinitis progression, defined as the time (days) from
initiating therapy until the advancement of 750-um over a 750 um front of any border of any
lesion was observed. Standardized nine-field photographs were taken at 2-week intervals and
analyzed in a masked fashion by the Fundus Photograph Reading Center to determine evidence of
CMV retinitis progression.

Secondary end points included time to development of CMV retinitis in the contralateral eye,
time to development of visceral CMV, and time to death.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>October 1992</start_date>
<completion_date type="Actual">December 1993</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>HIV Infections</condition>
<condition>Acquired Immunodeficiency Syndrome</condition>
<condition>Cytomegalovirus Retinitis</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Sustained-Release Intraocular Drug Delivery System</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
All patients must have had AIDS as defined by the Centers for Disease Control and
Prevention and non-sight-threatening CMV retinitis Patients could not have been previously
treated with systemic ganciclovir or foscarnet and must not have had evidence of other
organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC)
greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-soca-fgcrt.asp</url>
<description>Clinical Alert To Physicians And Others Who Treat Patients With AIDS</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/gipressrelease.asp</url>
<description>NEI Press Release-Eye Implant Effective in Treating CMV Retinitis</description>
</link>
<reference>
<citation>Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.</citation>
<PMID>7993207</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>HIV Infections</mesh_term>
<mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
<mesh_term>Immunologic Deficiency Syndromes</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000118
org study id: NEI-14
nct id: NCT00000118
lead sponsor:
To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system
for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired
immunodeficiency syndrome (AIDS).
CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of
visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that
have been approved by the U.S. Food and Drug Administration for the treatment of CMV
retinitis. The therapeutic regimen for each drug consists of a 2-week induction period
followed by daily maintenance intravenous infusions. Unfortunately, CMV retinitis usually
progresses despite daily maintenance therapy, and both drugs are associated with significant
systemic toxicity that often limits their therapeutic usefulness. As an alternative to
intravenous administration, direct intravitreal injections of ganciclovir have been studied
and have been shown to be effective in delaying the progression of CMV retinitis. The short
half-life of the drug, however, necessitates one to two intraocular injections a week to
maintain therapeutic levels. Widespread adoption of this technique has been limited because
of the logistical difficulties and inherent risks associated with numerous intravitreal
injections.
A drug delivery system capable of continuous delivery of ganciclovir into the vitreous cavity
has been developed. The device consists of a 6-mg pellet of ganciclovir that is coated with a
series of polymers with variable permeability to ganciclovir. The device is surgically
implanted through the pars plana.
Thirty eyes of 26 patients with unilateral non-sight-threatening CMV retinitis were randomly
assigned to one of two groups: (1) immediate therapy with a device designed to release
ganciclovir into the vitreous cavity a over approximately a 4-month period or (2) deferred
treatment. In patients with bilateral non-sight-threatening CMV retinitis, one eye was
randomly assigned to receive a ganciclovir implant with the other eye assigned to deferred
treatment. (Note: The original trial design included a third randomized arm using a 2 ug/hour
device. This arm was dropped for logistical reasons after enrolling two patients.)
Patients assigned to immediate treatment underwent surgery to implant the ganciclovir device
within 48 hours of enrollment and baseline photographs. Postoperatively, patients were
evaluated the next day, weekly for 2 weeks, and then every 2 weeks until progression of CMV
retinitis occurred. At each examination, in both eyes, visual acuity with current correction
and best correction was determined using Early Treatment Diabetic Retinopathy Study eye
charts; intraocular pressure was determined; evidence of inflammation or cataract was
evaluated; and all retinal findings were documented. Any adverse event considered even
possibly related to the device or to the implantation procedure was documented. Standardized
nine-field fundus photographs were taken at each 2-week visit. The ganciclovir implant was
exchanged at 32 weeks or earlier if progression of CMV retinitis occurred.
The primary end point was time to CMV retinitis progression, defined as the time (days) from
initiating therapy until the advancement of 750-um over a 750 um front of any border of any
lesion was observed. Standardized nine-field photographs were taken at 2-week intervals and
analyzed in a masked fashion by the Fundus Photograph Reading Center to determine evidence of
CMV retinitis progression.
Secondary end points included time to development of CMV retinitis in the contralateral eye,
time to development of visceral CMV, and time to death.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Sustained-Release Intraocular Drug Delivery System
criteria:
gender: All
minimum age: N/A
maximum age: N/A
url: http://www.nei.nih.gov/news/clinicalalerts/alert-soca-fgcrt.asp
description: Clinical Alert To Physicians And Others Who Treat Patients With AIDS
url: http://www.nei.nih.gov/news/pressreleases/gipressrelease.asp
description: NEI Press Release-Eye Implant Effective in Treating CMV Retinitis
citation: Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.
PMID: 7993207
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Immunologic Deficiency Syndromes
|
NCT0000xxxx/NCT00000119.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000119</url>
</required_header>
<id_info>
<org_study_id>NEI-15</org_study_id>
<nct_id>NCT00000119</nct_id>
</id_info>
<brief_title>Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in
patients with uveitis undergoing cataract surgery.

To evaluate the safety and efficacy of intraocular lens implantation in patients with severe
uveitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Patients with uveitis are at high risk for significant complications following cataract
surgery with intraocular lens implantation. Complications may result from the surgery itself
or may develop after surgery as a result of the intraocular lens. Complications related to
intraocular lens implantation include iris adhesions to the intraocular lens, which can
result in lens capture; cellular deposits on the surface of the lens that can obscure vision;
and uveitis. Recent studies have identified giant cells on the anterior surface of
intraocular lenses in some patients with uveitis, appearing to indicate an intraocular
lens-induced inflammatory response. Some of these patients have required multiple YAG laser
procedures to remove these deposits.

Modification of the surface of the intraocular lens with a layer of heparin may provide a
more biocompatible surface. Preclinical studies have shown a reduction in the degree of
postoperative complications with the heparin surface-modified intraocular lens compared with
an unmodified lens. Although retrospective case series have examined the use of heparin
surface-modified intraocular lenses in patients with uveitis, a randomized, controlled
clinical trial has not been performed.

This is a randomized clinical trial examining the safety and efficacy of the heparin
surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of
uveitis in an eye requiring cataract surgery will be randomized to receive a heparin
surface-modified intraocular lens or the same model of intraocular lens without surface
modification. The primary end point of the study will be the development of cellular deposits
on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits
will be assessed by a masked grader using standard photographs. Secondary end points will
include visual acuity, intraocular inflammation, development of anterior and posterior
synechiae, and corneal endothelial cell counts.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>March 1994</start_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Cataract</condition>
<condition>Uveitis</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Heparin Surface-Modified Intraocular Lens</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Women and men 18 years or older with a documented history of uveitis in an eye requiring
cataract surgery are eligible for the study. In all patients, the eye must be free of
active inflammation for at least 3 months before surgery, with or without anti-inflammatory
medications. Exclusion criteria include corneal pathology or hazy media that preclude
evaluation of the intraocular lens, uncontrolled glaucoma, and diabetes mellitus. Monocular
patients and patients who cannot be followed for at least 1 year are also excluded.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<location>
<facility>
<name>National Institutes of Health</name>
<address>
<city>Bethesda</city>
<state>Maryland</state>
<zip>20892-1858</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cataract</mesh_term>
<mesh_term>Uveitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Heparin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000119
org study id: NEI-15
nct id: NCT00000119
lead sponsor:
To investigate the safety and efficacy of a heparin surface-modified intraocular lens in
patients with uveitis undergoing cataract surgery.
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe
uveitis.
Patients with uveitis are at high risk for significant complications following cataract
surgery with intraocular lens implantation. Complications may result from the surgery itself
or may develop after surgery as a result of the intraocular lens. Complications related to
intraocular lens implantation include iris adhesions to the intraocular lens, which can
result in lens capture; cellular deposits on the surface of the lens that can obscure vision;
and uveitis. Recent studies have identified giant cells on the anterior surface of
intraocular lenses in some patients with uveitis, appearing to indicate an intraocular
lens-induced inflammatory response. Some of these patients have required multiple YAG laser
procedures to remove these deposits.
Modification of the surface of the intraocular lens with a layer of heparin may provide a
more biocompatible surface. Preclinical studies have shown a reduction in the degree of
postoperative complications with the heparin surface-modified intraocular lens compared with
an unmodified lens. Although retrospective case series have examined the use of heparin
surface-modified intraocular lenses in patients with uveitis, a randomized, controlled
clinical trial has not been performed.
This is a randomized clinical trial examining the safety and efficacy of the heparin
surface-modified intraocular lens in patients with uveitis. Eighty patients with a history of
uveitis in an eye requiring cataract surgery will be randomized to receive a heparin
surface-modified intraocular lens or the same model of intraocular lens without surface
modification. The primary end point of the study will be the development of cellular deposits
on the anterior surface of the intraocular lens 1 year after surgery. These cellular deposits
will be assessed by a masked grader using standard photographs. Secondary end points will
include visual acuity, intraocular inflammation, development of anterior and posterior
synechiae, and corneal endothelial cell counts.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Heparin Surface-Modified Intraocular Lens
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
facility:
country: United States
mesh term: Cataract
mesh term: Uveitis
mesh term: Heparin
|
NCT0000xxxx/NCT00000120.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000120</url>
</required_header>
<id_info>
<org_study_id>NEI-19</org_study_id>
<nct_id>NCT00000120</nct_id>
</id_info>
<brief_title>Clinical Trial of Eye Prophylaxis in the Newborn</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication
in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye
infections.

To compare side effects of the two prophylactic agents.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Sexually transmitted diseases are a major cause of neonatal eye infections. All 50 States
require some eye treatment at birth to prevent gonorrheal eye infections. Approximately 3 to
4 million Americans acquire a genital chlamydial infection each year, and more than 150,000
infants are born to mothers with chlamydial infections. These infants are at high risk of
developing conjunctivitis and pneumonia.

In the State of Washington, one of three treatments is presently required by law to help
prevent gonorrheal eye infection in newborn babies: 1 percent silver nitrate drops,
erythromycin ointment, or tetracycline ointment. Although all three treatments appear to
prevent eye infections from gonorrhea, silver nitrate and erythromycin may also partially
prevent chlamydial conjunctivitis. However, silver nitrate may irritate and damage the eyes
of newborns.

If it is not known whether the mother is infected, it may be better not to give the drugs
routinely. It could not be clearly established from the medical literature whether the risk
to infants from no treatment was higher or lower than the risk from receiving a prophylactic
agent. Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their
newborns. Moreover, Great Britain, which used no eye prophylactic agents for newborns for the
25 years preceding the study, has rates of neonatal conjunctivitis similar to those in the
United States. For these reasons, the Washington State Board of Health granted this study an
exemption from the State law to allow the investigators to evaluate scientifically the risks
and benefits of no treatment.

The study was a randomized, double-masked clinical trials planned to include 1,200 infants
born over 3 years. The trial compared the efficacy of two treatment regimens (silver nitrate
and erythromycin) in two treatment groups to the outcomes in a control group receiving no
prophylaxis. (Erythromycin was chosen over tetracycline as the antibiotic in this study
because it is more commonly used in the United States for ocular prophylaxis.)

Women were recruited from the University of Washington Medical Center-associated obstetric
units. Among the 2,577 women eligible for possible participation, 758 enrolled. Of these
participants, 89 were not randomized. Among the 669 randomized women, 39 were not available
for personal observation. These 39 were equally distributed among the three prophylaxis
groups. In the final participant group, the infants of 630 women were evaluable.

The infants were randomly assigned to one of these three groups in the delivery room. Infants
without conjunctivitis were monitored for 2 months after delivery. Infants who developed
conjunctivitis were monitored for 2 months after successful treatment of their infection. The
study included extensive efforts to determine the etiology of the conjunctivitis and to find
nasolacrimal duct obstruction.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1985</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Chlamydia Infections</condition>
<condition>Ophthalmia Neonatorum</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Erythromycin Ointment</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Silver Nitrate Drops</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The study included male and female infants delivered at University Hospital in Seattle,
Washington. Women were recruited after the 28th week of pregnancy and had to be
English-speaking. In addition, they planned to stay at the hospital at least 48 hours
following delivery and lived in the greater Seattle metropolitan area. Infants were
eligible whether they were delivered vaginally or by cesarean section. Excluded from the
study were siblings of infants enrolled in the study, women who were culture-positive for
gonorrhea, infants receiving systemic antimicrobials for reasons other than conjunctivitis,
women receiving antimicrobials at the time of delivery, and families unlikely to be
available for followup after delivery.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>1 Year</maximum_age>
</eligibility>
<reference>
<citation>Krohn MA, Hillier SL, Bell TA, Kronmal RA, Grayston JT. The bacterial etiology of conjunctivitis in early infancy. Eye Prophylaxis Study Group. Am J Epidemiol. 1993 Sep 1;138(5):326-32. doi: 10.1093/oxfordjournals.aje.a116862.</citation>
<PMID>8356971</PMID>
</reference>
<reference>
<citation>Bell TA, Grayston JT, Krohn MA, Kronmal RA. Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group. Pediatrics. 1993 Dec;92(6):755-60.</citation>
<PMID>8233733</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Neonatal Conjunctivitis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Chlamydia Infections</mesh_term>
<mesh_term>Ophthalmia Neonatorum</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Erythromycin</mesh_term>
<mesh_term>Erythromycin Estolate</mesh_term>
<mesh_term>Erythromycin Ethylsuccinate</mesh_term>
<mesh_term>Erythromycin stearate</mesh_term>
<mesh_term>Silver Nitrate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000120
org study id: NEI-19
nct id: NCT00000120
lead sponsor:
To compare the effectiveness of silver nitrate drops, erythromycin ointment, or no medication
in preventing neonatal conjunctivitis caused by Chlamydia trachomatis and other eye
infections.
To compare side effects of the two prophylactic agents.
Sexually transmitted diseases are a major cause of neonatal eye infections. All 50 States
require some eye treatment at birth to prevent gonorrheal eye infections. Approximately 3 to
4 million Americans acquire a genital chlamydial infection each year, and more than 150,000
infants are born to mothers with chlamydial infections. These infants are at high risk of
developing conjunctivitis and pneumonia.
In the State of Washington, one of three treatments is presently required by law to help
prevent gonorrheal eye infection in newborn babies: 1 percent silver nitrate drops,
erythromycin ointment, or tetracycline ointment. Although all three treatments appear to
prevent eye infections from gonorrhea, silver nitrate and erythromycin may also partially
prevent chlamydial conjunctivitis. However, silver nitrate may irritate and damage the eyes
of newborns.
If it is not known whether the mother is infected, it may be better not to give the drugs
routinely. It could not be clearly established from the medical literature whether the risk
to infants from no treatment was higher or lower than the risk from receiving a prophylactic
agent. Many parents at low risk for gonorrhea prefer that no prophylaxis be given to their
newborns. Moreover, Great Britain, which used no eye prophylactic agents for newborns for the
25 years preceding the study, has rates of neonatal conjunctivitis similar to those in the
United States. For these reasons, the Washington State Board of Health granted this study an
exemption from the State law to allow the investigators to evaluate scientifically the risks
and benefits of no treatment.
The study was a randomized, double-masked clinical trials planned to include 1,200 infants
born over 3 years. The trial compared the efficacy of two treatment regimens (silver nitrate
and erythromycin) in two treatment groups to the outcomes in a control group receiving no
prophylaxis. (Erythromycin was chosen over tetracycline as the antibiotic in this study
because it is more commonly used in the United States for ocular prophylaxis.)
Women were recruited from the University of Washington Medical Center-associated obstetric
units. Among the 2,577 women eligible for possible participation, 758 enrolled. Of these
participants, 89 were not randomized. Among the 669 randomized women, 39 were not available
for personal observation. These 39 were equally distributed among the three prophylaxis
groups. In the final participant group, the infants of 630 women were evaluable.
The infants were randomly assigned to one of these three groups in the delivery room. Infants
without conjunctivitis were monitored for 2 months after delivery. Infants who developed
conjunctivitis were monitored for 2 months after successful treatment of their infection. The
study included extensive efforts to determine the etiology of the conjunctivitis and to find
nasolacrimal duct obstruction.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Erythromycin Ointment
intervention type: Drug
intervention name: Silver Nitrate Drops
criteria:
gender: All
minimum age: N/A
maximum age: 1 Year
citation: Krohn MA, Hillier SL, Bell TA, Kronmal RA, Grayston JT. The bacterial etiology of conjunctivitis in early infancy. Eye Prophylaxis Study Group. Am J Epidemiol. 1993 Sep 1;138(5):326-32. doi: 10.1093/oxfordjournals.aje.a116862.
PMID: 8356971
citation: Bell TA, Grayston JT, Krohn MA, Kronmal RA. Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group. Pediatrics. 1993 Dec;92(6):755-60.
PMID: 8233733
mesh term: Chlamydia Infections
mesh term: Ophthalmia Neonatorum
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate
mesh term: Silver Nitrate
|
NCT0000xxxx/NCT00000121.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000121</url>
</required_header>
<id_info>
<org_study_id>NEI-20</org_study_id>
<nct_id>NCT00000121</nct_id>
</id_info>
<brief_title>The Prism Adaptation Study (PAS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of
surgery for acquired esotropia, a type of strabismus.

To determine whether patients who respond to prism adaptation by developing a new stable
angle of -deviation have a better surgical result than do patients who do not respond to
prism adaptation.

To determine whether patients who respond to prism adaptation are more accurately corrected
by operating for the prism-adapted angle or the original angle of deviation.

To determine the usefulness of certain input variables (e.g., age at the time of surgery,
size of the deviation, visual acuity, binocular function, refractive error) in predicting
which patients are more likely to benefit from prism adaptation.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months)
accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is
done primarily to attain functional use of the two eyes together. The cosmetic aspect of the
surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to
accomplish the primary goal, and in some cases even three and four operations are needed.

Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses
for about a month before surgery led to good results after a single operation in more than 90
percent of patients. These uncontrolled preliminary studies pointed to the need for a
multicenter, randomized, controlled clinical trial designed to prove or disprove
scientifically the beneficial effect of prisms.

The Prism Adaptation Study was a double randomization trial involving 286 patients.
Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of
the patients who responded to the prisms, one-half were randomly selected to have surgery
based on the amount of prism required to stabilize the deviation, and the other half had
surgery based on the amount of esotropia originally measured. Patients who did not respond to
the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths
of the patients who did not undergo prism adaptation.

Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An
independent examiner, masked to the treatment assignment, evaluated the patient at the
6-month followup. The results were analyzed to determine whether the outcome was better in
patients who underwent prism adaptation or in those who underwent conventional treatment.
Because the examiner did not know what type of treatment a patient had received, he or she
would have no bias in evaluating the results.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>March 1984</start_date>
<completion_date type="Actual">May 1989</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Esotropia</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Prisms in Eyeglasses</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
An eligible male or female must have been age 3 years or older (adults were included) and
must have had esotropia that occurred at age 6 months or older, with no history of previous
eye muscle surgery.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>3 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<reference>
<citation>Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. Arch Ophthalmol. 1990 Sep;108(9):1248-56. doi: 10.1001/archopht.1990.01070110064026.</citation>
<PMID>2100986</PMID>
</reference>
<reference>
<citation>Repka MX, Connett JE, Scott WE. The one-year surgical outcome after prism adaptation for the management of acquired esotropia. Ophthalmology. 1996 Jun;103(6):922-8. doi: 10.1016/s0161-6420(96)30586-1.</citation>
<PMID>8643248</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>strabismus</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esotropia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000121
org study id: NEI-20
nct id: NCT00000121
lead sponsor:
To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of
surgery for acquired esotropia, a type of strabismus.
To determine whether patients who respond to prism adaptation by developing a new stable
angle of -deviation have a better surgical result than do patients who do not respond to
prism adaptation.
To determine whether patients who respond to prism adaptation are more accurately corrected
by operating for the prism-adapted angle or the original angle of deviation.
To determine the usefulness of certain input variables (e.g., age at the time of surgery,
size of the deviation, visual acuity, binocular function, refractive error) in predicting
which patients are more likely to benefit from prism adaptation.
Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months)
accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is
done primarily to attain functional use of the two eyes together. The cosmetic aspect of the
surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to
accomplish the primary goal, and in some cases even three and four operations are needed.
Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses
for about a month before surgery led to good results after a single operation in more than 90
percent of patients. These uncontrolled preliminary studies pointed to the need for a
multicenter, randomized, controlled clinical trial designed to prove or disprove
scientifically the beneficial effect of prisms.
The Prism Adaptation Study was a double randomization trial involving 286 patients.
Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of
the patients who responded to the prisms, one-half were randomly selected to have surgery
based on the amount of prism required to stabilize the deviation, and the other half had
surgery based on the amount of esotropia originally measured. Patients who did not respond to
the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths
of the patients who did not undergo prism adaptation.
Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An
independent examiner, masked to the treatment assignment, evaluated the patient at the
6-month followup. The results were analyzed to determine whether the outcome was better in
patients who underwent prism adaptation or in those who underwent conventional treatment.
Because the examiner did not know what type of treatment a patient had received, he or she
would have no bias in evaluating the results.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Prisms in Eyeglasses
criteria:
gender: All
minimum age: 3 Years
maximum age: N/A
citation: Efficacy of prism adaptation in the surgical management of acquired esotropia. Prism Adaptation Study Research Group. Arch Ophthalmol. 1990 Sep;108(9):1248-56. doi: 10.1001/archopht.1990.01070110064026.
PMID: 2100986
citation: Repka MX, Connett JE, Scott WE. The one-year surgical outcome after prism adaptation for the management of acquired esotropia. Ophthalmology. 1996 Jun;103(6):922-8. doi: 10.1016/s0161-6420(96)30586-1.
PMID: 8643248
mesh term: Esotropia
|
NCT0000xxxx/NCT00000122.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000122</url>
</required_header>
<id_info>
<org_study_id>NEI-21</org_study_id>
<nct_id>NCT00000122</nct_id>
</id_info>
<brief_title>Fluorouracil Filtering Surgery Study (FFSS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU)
increase the success rate of filtering surgery in patients at high risk for failure after
standard glaucoma filtering surgery.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Filtering surgery adequately lowers intraocular pressure in most glaucoma patients. However,
the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes
following unsuccessful filtering operations. Failure of filtering surgery is usually
attributed to the proliferation of fibroblasts at the filtering site. The use of 5-FU, an
antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture,
and in preliminary studies it has increased the success of filtering surgery in a nonhuman
primate model.

The Fluorouracil Filtering Surgery Study (FFSS) was a randomized, controlled clinical trial
comparing the success rate of standard glaucoma filtering surgery to the success rate of
standard surgery with adjunctive 5-FU treatment.

Another element of this study was to evaluate the frequency and severity of possible adverse
effects related to 5-FU injections. Detailed preoperative and postoperative examinations of
the cornea, lens, and retina were performed. Systemic toxicity was assessed by preoperative
and postoperative hematologic studies.

After the investigators performed the filtering surgery and determined that the new outlet
channel was working, patients were randomized to receive either 5-FU injections or standard
postsurgical care without 5-FU. The patients treated with 5-FU received subconjunctival
injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on
postoperative days 8 through 14. There were 213 patients recruited into the study, 162 with
previous cataract extraction and 51 with previous filtering surgery.

All patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years
postoperatively and at yearly intervals thereafter until 5 years postoperatively. Possible
concomitant risks of 5-FU treatment, such as toxic effects to the cornea, lens, or retina,
were monitored.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1985</start_date>
<completion_date type="Actual">June 1988</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Glaucoma</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>5-Fluorouracil</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women with uncontrolled intraocular pressure greater than 21 mm Hg in one or both
eyes despite maximal tolerated therapy and who were aphakic or had undergone previous
filtering surgery were eligible to participate.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/ffsspressrelease.asp</url>
<description>NEI Press Release-Fluorouracil Improves Glaucoma Surgery Outcome</description>
</link>
<reference>
<citation>Fluorouracil Filtering Surgery Study one-year follow-up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15;108(6):625-35. doi: 10.1016/0002-9394(89)90853-2.</citation>
<PMID>2688428</PMID>
</reference>
<reference>
<citation>Risk factors for suprachoroidal hemorrhage after filtering surgery. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1992 May 15;113(5):501-7. doi: 10.1016/s0002-9394(14)74720-8.</citation>
<PMID>1575223</PMID>
</reference>
<reference>
<citation>Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol. 1993 Jan;115(1):82-92. doi: 10.1016/s0002-9394(14)73529-9.</citation>
<PMID>8420383</PMID>
</reference>
<reference>
<citation>Five-year follow-up of the Fluorouracil Filtering Surgery Study. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1996 Apr;121(4):349-66. doi: 10.1016/s0002-9394(14)70431-3.</citation>
<PMID>8604728</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Fluorouracil</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000122
org study id: NEI-21
nct id: NCT00000122
lead sponsor:
To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU)
increase the success rate of filtering surgery in patients at high risk for failure after
standard glaucoma filtering surgery.
Filtering surgery adequately lowers intraocular pressure in most glaucoma patients. However,
the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes
following unsuccessful filtering operations. Failure of filtering surgery is usually
attributed to the proliferation of fibroblasts at the filtering site. The use of 5-FU, an
antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture,
and in preliminary studies it has increased the success of filtering surgery in a nonhuman
primate model.
The Fluorouracil Filtering Surgery Study (FFSS) was a randomized, controlled clinical trial
comparing the success rate of standard glaucoma filtering surgery to the success rate of
standard surgery with adjunctive 5-FU treatment.
Another element of this study was to evaluate the frequency and severity of possible adverse
effects related to 5-FU injections. Detailed preoperative and postoperative examinations of
the cornea, lens, and retina were performed. Systemic toxicity was assessed by preoperative
and postoperative hematologic studies.
After the investigators performed the filtering surgery and determined that the new outlet
channel was working, patients were randomized to receive either 5-FU injections or standard
postsurgical care without 5-FU. The patients treated with 5-FU received subconjunctival
injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on
postoperative days 8 through 14. There were 213 patients recruited into the study, 162 with
previous cataract extraction and 51 with previous filtering surgery.
All patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years
postoperatively and at yearly intervals thereafter until 5 years postoperatively. Possible
concomitant risks of 5-FU treatment, such as toxic effects to the cornea, lens, or retina,
were monitored.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: 5-Fluorouracil
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/ffsspressrelease.asp
description: NEI Press Release-Fluorouracil Improves Glaucoma Surgery Outcome
citation: Fluorouracil Filtering Surgery Study one-year follow-up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15;108(6):625-35. doi: 10.1016/0002-9394(89)90853-2.
PMID: 2688428
citation: Risk factors for suprachoroidal hemorrhage after filtering surgery. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1992 May 15;113(5):501-7. doi: 10.1016/s0002-9394(14)74720-8.
PMID: 1575223
citation: Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol. 1993 Jan;115(1):82-92. doi: 10.1016/s0002-9394(14)73529-9.
PMID: 8420383
citation: Five-year follow-up of the Fluorouracil Filtering Surgery Study. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1996 Apr;121(4):349-66. doi: 10.1016/s0002-9394(14)70431-3.
PMID: 8604728
mesh term: Glaucoma
mesh term: Fluorouracil
|
NCT0000xxxx/NCT00000123.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000123</url>
</required_header>
<id_info>
<org_study_id>NEI-22</org_study_id>
<nct_id>NCT00000123</nct_id>
</id_info>
<brief_title>The Berkeley Orthokeratology Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in
central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal
curvature.

To evaluate the relative safety of orthokeratology, primarily by assessment of changes in
central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced
corneal edema, and epithelial staining.

To assess the duration of any orthokeratology treatment effect.

To study the mechanisms by which refractive error and visual acuity changes occur, in
particular the contribution that comes from changes in corneal curvature and shape.

To determine whether there were any predisposing ocular factors that could be used to predict
which subjects will experience changes or complications.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In the early 1960s, a group of clinicians asserted that myopia could be reduced and possibly
corrected by fitting specially designed contact lenses to induce corneal flattening and
thereby reduce the refractive power of the eye. This technique, known as orthokeratology,
required that the lenses be fitted and then changed progressively until vision becomes normal
or nearly normal. Advocates of orthokeratology claimed that corneal changes could be induced
in a predictable fashion, were often permanent, and occurred without causing any adverse
effects to the cornea. Data on orthokeratology were generally limited, poorly documented, and
did not address the issues of control or failure.

The Berkeley Orthokeratology Study was a single center randomized, concurrently controlled,
masked clinical trial. Corneal and visual changes in an orthokeratology treatment group were
monitored and compared with those observed in a control group whose members wore contact
lenses fitted in a standard clinical manner. Visual and ocular characteristics were monitored
for 1.5 years.

Eighty subjects were studied-40 in an orthokeratology group and 40 in a control group fitted
with conventional hard contact lenses. The hard lenses chosen for this study were made of
either polymethyl methacrylate (PMMA) or a PMMA-silicone combination (Polycon). All subjects
were initially fitted with PMMA lenses.

The initial treatment and control lenses were selected according to protocol guidelines and
then adjusted to achieve an "optimal fit" based on lens position, movement, and alignment as
assessed by fluorescein study. At the outset, the treatment and control lenses differed in
that the treatment lenses were on the average thicker and flatter and had a larger diameter.

Following the dispensing visit, subjects progressed through three study phases. In the
adaption phase (Phase A), subjects were examined weekly until they were adapted to 12 to 14
hours of daily contact lens wear. The postadaptive phase (Phase B) consisted of monthly
followup examinations for 1 year. The final phase (Phase C) consisted of a lens withdrawal
segment and a postwearing segment.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1978</start_date>
<completion_date type="Actual">February 1979</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Astigmatism</condition>
<condition>Myopia</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Polymethyl Methacrylate-Silicone Contact Lenses</intervention_name>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Polymethyl Methacrylate Contact Lenses</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Myopic volunteers, ages 20 to 35, who had not worn contact lenses were eligible to
participate in the study if they were free of ocular disease, were in good physical health,
and were not taking systemic medications that could have ocular side effects. In addition,
eligibility was limited to persons with corneal curvature between 40.50 and 47.00 D
(flatter keratometry reading), corrected visual acuity of 6/6 (20/20) or better in each
eye, astigmatism less than 0.75 D, anisometropia less than 1 D, and myopia between 1 and 4
D.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>20 Years</minimum_age>
<maximum_age>35 Years</maximum_age>
</eligibility>
<reference>
<citation>Polse KA, Brand RJ. Contact lens effects on ametropia: a current example of the clinical trial. Am J Optom Physiol Opt. 1981 Apr;58(4):281-8.</citation>
<PMID>7282852</PMID>
</reference>
<reference>
<citation>Brand RJ, Polse KA, Schwalbe JS. The Berkeley Orthokeratology Study, Part I: General conduct of the study. Am J Optom Physiol Opt. 1983 Mar;60(3):175-86. doi: 10.1097/00006324-198303000-00005.</citation>
<PMID>6342407</PMID>
</reference>
<reference>
<citation>Polse KA, Brand RJ, Keener RJ, Schwalbe JS, Vastine DW. The Berkeley Orthokeratology Study, part III: safety. Am J Optom Physiol Opt. 1983 Apr;60(4):321-8. doi: 10.1097/00006324-198304000-00011.</citation>
<PMID>6344645</PMID>
</reference>
<reference>
<citation>Polse KA, Brand RJ, Schwalbe JS, Vastine DW, Keener RJ. The Berkeley Orthokeratology Study, Part II: Efficacy and duration. Am J Optom Physiol Opt. 1983 Mar;60(3):187-98. doi: 10.1097/00006324-198303000-00006.</citation>
<PMID>6342408</PMID>
</reference>
<reference>
<citation>Polse KA, Brand RJ, Vastine DW, Schwalbe JS. Corneal change accompanying orthokeratology. Plastic or elastic? Results of a randomized controlled clinical trial. Arch Ophthalmol. 1983 Dec;101(12):1873-8. doi: 10.1001/archopht.1983.01040020875008.</citation>
<PMID>6360111</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Astigmatism</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Polymethyl Methacrylate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000123
org study id: NEI-22
nct id: NCT00000123
lead sponsor:
To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in
central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal
curvature.
To evaluate the relative safety of orthokeratology, primarily by assessment of changes in
central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced
corneal edema, and epithelial staining.
To assess the duration of any orthokeratology treatment effect.
To study the mechanisms by which refractive error and visual acuity changes occur, in
particular the contribution that comes from changes in corneal curvature and shape.
To determine whether there were any predisposing ocular factors that could be used to predict
which subjects will experience changes or complications.
In the early 1960s, a group of clinicians asserted that myopia could be reduced and possibly
corrected by fitting specially designed contact lenses to induce corneal flattening and
thereby reduce the refractive power of the eye. This technique, known as orthokeratology,
required that the lenses be fitted and then changed progressively until vision becomes normal
or nearly normal. Advocates of orthokeratology claimed that corneal changes could be induced
in a predictable fashion, were often permanent, and occurred without causing any adverse
effects to the cornea. Data on orthokeratology were generally limited, poorly documented, and
did not address the issues of control or failure.
The Berkeley Orthokeratology Study was a single center randomized, concurrently controlled,
masked clinical trial. Corneal and visual changes in an orthokeratology treatment group were
monitored and compared with those observed in a control group whose members wore contact
lenses fitted in a standard clinical manner. Visual and ocular characteristics were monitored
for 1.5 years.
Eighty subjects were studied-40 in an orthokeratology group and 40 in a control group fitted
with conventional hard contact lenses. The hard lenses chosen for this study were made of
either polymethyl methacrylate (PMMA) or a PMMA-silicone combination (Polycon). All subjects
were initially fitted with PMMA lenses.
The initial treatment and control lenses were selected according to protocol guidelines and
then adjusted to achieve an "optimal fit" based on lens position, movement, and alignment as
assessed by fluorescein study. At the outset, the treatment and control lenses differed in
that the treatment lenses were on the average thicker and flatter and had a larger diameter.
Following the dispensing visit, subjects progressed through three study phases. In the
adaption phase (Phase A), subjects were examined weekly until they were adapted to 12 to 14
hours of daily contact lens wear. The postadaptive phase (Phase B) consisted of monthly
followup examinations for 1 year. The final phase (Phase C) consisted of a lens withdrawal
segment and a postwearing segment.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Device
intervention name: Polymethyl Methacrylate-Silicone Contact Lenses
intervention type: Device
intervention name: Polymethyl Methacrylate Contact Lenses
criteria:
gender: All
minimum age: 20 Years
maximum age: 35 Years
citation: Polse KA, Brand RJ. Contact lens effects on ametropia: a current example of the clinical trial. Am J Optom Physiol Opt. 1981 Apr;58(4):281-8.
PMID: 7282852
citation: Brand RJ, Polse KA, Schwalbe JS. The Berkeley Orthokeratology Study, Part I: General conduct of the study. Am J Optom Physiol Opt. 1983 Mar;60(3):175-86. doi: 10.1097/00006324-198303000-00005.
PMID: 6342407
citation: Polse KA, Brand RJ, Keener RJ, Schwalbe JS, Vastine DW. The Berkeley Orthokeratology Study, part III: safety. Am J Optom Physiol Opt. 1983 Apr;60(4):321-8. doi: 10.1097/00006324-198304000-00011.
PMID: 6344645
citation: Polse KA, Brand RJ, Schwalbe JS, Vastine DW, Keener RJ. The Berkeley Orthokeratology Study, Part II: Efficacy and duration. Am J Optom Physiol Opt. 1983 Mar;60(3):187-98. doi: 10.1097/00006324-198303000-00006.
PMID: 6342408
citation: Polse KA, Brand RJ, Vastine DW, Schwalbe JS. Corneal change accompanying orthokeratology. Plastic or elastic? Results of a randomized controlled clinical trial. Arch Ophthalmol. 1983 Dec;101(12):1873-8. doi: 10.1001/archopht.1983.01040020875008.
PMID: 6360111
mesh term: Astigmatism
mesh term: Polymethyl Methacrylate
|
NCT0000xxxx/NCT00000124.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000124</url>
</required_header>
<id_info>
<org_study_id>NEI-23</org_study_id>
<nct_id>NCT00000124</nct_id>
</id_info>
<brief_title>Collaborative Ocular Melanoma Study (COMS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate therapeutic interventions for patients who have choroidal melanoma, the most
common primary eye cancer affecting adults, and to assess the potential life-preserving as
well as sight-preserving role of radiation therapy.

To determine which of two standard treatments, removal of the eye or brachytherapy, is more
likely to prolong survival of eligible patients with medium-sized choroidal melanoma.

To determine whether preoperative radiation prolongs life for patients whose eyes with large
choroidal melanoma are enucleated.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
For more than 100 years, removal of the eye (enucleation) has been the standard treatment for
choroidal melanoma. Before the COMS was initiated in 1986, interest in radiation therapy had
increased because of the potential for saving the eye and perhaps some vision. However, the
merits of radiation with respect to prolonging patient survival were unknown. The best data
from nonrandomized studies suggested that there was no difference in length of remaining life
between patients treated with radiation and those whose eyes were enucleated. Thus, it was
appropriate and necessary to conduct a randomized, controlled clinical trial in which a large
number of patients would be followed for many years in order to compare enucleation and
radiation with respect to relative success in prolonging survival of choroidal melanoma
patients.

The Collaborative Ocular Melanoma Study (COMS) is a set of long-term, multicenter, randomized
controlled trials. In the trial for patients with tumors of medium size, enucleation and
irradiation with an iodine-125 episcleral plaque are compared on the basis of length of
remaining life. All randomized patients will be followed for 5 to 15 years or until death.
For patients randomly assigned to enucleation, the eye was removed following a standard
procedure. For patients assigned to plaque irradiation, the margins of the tumor were located
and the dimensions of the tumor were measured by the ophthalmic surgeon. A gold plaque with a
plastic seed carrier that contained the proper dosage and configuration of radioactive iodine
seeds was sutured to the outside (sclera) of the eye over the base of the tumor. This
procedure made possible the delivery of a high dose of radiation to a very localized area (85
Gy [TG-43] to the tumor apex). The plaque typically was removed from the eye after three to
seven days. Enrollment was completed in this trial in July 1998 with 1,317 patients enrolled.
Clinical follow-up of patients will end in July 2003.

In the COMS trial of preoperative radiation, patients with large tumors were randomized to
enucleation alone or to enucleation preceded by 20 Gy of external beam radiation. The two
randomly assigned groups of patients were followed for at least five years or until death and
have been compared on the basis of length of remaining life and other outcomes. Enrollment in
this trial was completed in December 1994, with 1,003 patients enrolled. Clinical follow-up
of all patients in this trial ended in July 2000.

Accrual to a nonrandomized pilot study to assess the feasibility of a randomized trial for
small tumors was halted in 1989. Additional followup of those 204 patients was carried out
from 1994 to 1996.

The COMS is conducted in 43 clinical centers located in major population areas of the United
States and Canada. Six resource centers participate and have major roles in quality assurance
for the study. Information gathered and analyzed includes time to death from all causes, time
to death from cancer (whether metastatic choroidal melanoma or not), diagnosis of other
tumors, complications of radiation, and changes in visual acuity. A parallel study of quality
of life for patients enrolled in the trial of radioactive plaque was initiated in January
1995. From November 1986 through July 1998, 8,712 patients with choroidal melanoma of all
sizes were screened for eligibility for a COMS clinical trial.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>November 1986</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Choroid Neoplasms</condition>
<condition>Uveitis</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Brachytherapy</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Eye Removal</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women eligible for the study must be age 21 or older, have primary choroidal
melanoma in only one eye, and have no evidence of metastatic disease. Accurate estimation
of tumor thickness by echography must also be possible.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/071201.asp</url>
<description>COMS Press Release July 12, 2001</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/coms.asp</url>
<description>COMS Press Release June 15, 1998</description>
</link>
<reference>
<citation>Byrne SF, Marsh MJ, Boldt HC, Green RL, Johnson RN, Wilson DJ. Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study COMS Report No. 13. Ophthalmic Epidemiol. 2002 Feb;9(1):11-27. doi: 10.1076/opep.9.1.11.1719.</citation>
<PMID>11815892</PMID>
</reference>
<reference>
<citation>Collaborative Ocular Melanoma Study Group. Sociodemographic and clinical predictors of participation in two randomized trials: findings from the Collaborative Ocular Melanoma Study COMS report no. 7. Control Clin Trials. 2001 Oct;22(5):526-37. doi: 10.1016/s0197-2456(01)00157-x.</citation>
<PMID>11578786</PMID>
</reference>
<reference>
<citation>Moy CS, Albert DM, Diener-West M, McCaffrey LD, Scully RE, Willson JK; Collaborative Ocular Melanoma Study Group, prepared by COMS Mortality Coding Committee. Cause-specific mortality coding. methods in the collaborative ocular melanoma study coms report no. 14. Control Clin Trials. 2001 Jun;22(3):248-62. doi: 10.1016/s0197-2456(01)00113-1.</citation>
<PMID>11384789</PMID>
</reference>
<reference>
<citation>Collaborative Ocular Melanoma Study Group.. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol. 2001 May;119(5):670-6. doi: 10.1001/archopht.119.5.670.</citation>
<PMID>11346394</PMID>
</reference>
<reference>
<citation>Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1.</citation>
<PMID>11158813</PMID>
</reference>
<reference>
<citation>Echography (Ultrasound) Procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part II. J Ophthalmic Nurs Technol. 1999 Sep-Oct;18(5):219-32. No abstract available.</citation>
<PMID>10847049</PMID>
</reference>
<reference>
<citation>Echography (ultrasound) procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part I. J Ophthalmic Nurs Technol. 1999 Jul-Aug;18(4):143-9. No abstract available.</citation>
<PMID>10847038</PMID>
</reference>
<reference>
<citation>Quality of life assessment in the collaborative ocular melanoma study: design and methods. COMS-QOLS Report No. 1. COMS Quality of Life Study Group. Ophthalmic Epidemiol. 1999 Mar;6(1):5-17. doi: 10.1076/opep.6.1.5.1565.</citation>
<PMID>10384680</PMID>
</reference>
<reference>
<citation>The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.</citation>
<PMID>9744369</PMID>
</reference>
<reference>
<citation>The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.</citation>
<PMID>9645716</PMID>
</reference>
<reference>
<citation>The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma I: characteristics of patients enrolled and not enrolled. COMS report no. 9. Am J Ophthalmol. 1998 Jun;125(6):767-78. doi: 10.1016/s0002-9394(98)00038-5.</citation>
<PMID>9645715</PMID>
</reference>
<reference>
<citation>Histopathologic characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma Study. COMS report no. 6. Am J Ophthalmol. 1998 Jun;125(6):745-66. doi: 10.1016/s0002-9394(98)00040-3.</citation>
<PMID>9645714</PMID>
</reference>
<reference>
<citation>Factors predictive of growth and treatment of small choroidal melanoma: COMS Report No. 5. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Dec;115(12):1537-44. doi: 10.1001/archopht.1997.01100160707007.</citation>
<PMID>9400787</PMID>
</reference>
<reference>
<citation>Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR. Clear cell differentiation in choroidal melanoma. COMS report no. 8. Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):894-8. doi: 10.1001/archopht.1997.01100160064010.</citation>
<PMID>9230830</PMID>
</reference>
<reference>
<citation>Mortality in patients with small choroidal melanoma. COMS report no. 4. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):886-93.</citation>
<PMID>9230829</PMID>
</reference>
<reference>
<citation>Wells CG, Bradford RH, Fish GE, Straatsma BR, Hawkins BS. Choroidal melanomas in American Indians. COMS Group. Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1996 Aug;114(8):1017-8. doi: 10.1001/archopht.1996.01100140225024. No abstract available.</citation>
<PMID>8694711</PMID>
</reference>
<reference>
<citation>Design and methods of a clinical trial for a rare condition: the Collaborative Ocular Melanoma Study. COMS Report No. 3. Control Clin Trials. 1993 Oct;14(5):362-91. doi: 10.1016/0197-2456(93)90052-f.</citation>
<PMID>8222668</PMID>
</reference>
<reference>
<citation>Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS report no. 1. Arch Ophthalmol. 1990 Sep;108(9):1268-73. doi: 10.1001/archopht.1990.01070110084030. Erratum In: Arch Ophthalmol 1990 Dec;108(12):1708.</citation>
<PMID>2205183</PMID>
</reference>
<reference>
<citation>Earle J, Kline RW, Robertson DM. Selection of iodine 125 for the Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1987 Jun;105(6):763-4. doi: 10.1001/archopht.1987.01060060049030. No abstract available.</citation>
<PMID>3579705</PMID>
</reference>
<reference>
<citation>Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul;119(7):969-82. doi: 10.1001/archopht.119.7.969.</citation>
<PMID>11448319</PMID>
</reference>
<reference>
<citation>Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17. Arch Ophthalmol. 2001 Jul;119(7):951-65. doi: 10.1001/archopht.119.7.951.</citation>
<PMID>11448318</PMID>
</reference>
<verification_date>June 2002</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 1, 2006</last_update_submitted>
<last_update_submitted_qc>June 1, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 2, 2006</last_update_posted>
<keyword>Choroidal Melanoma</keyword>
<keyword>Ocular Melanoma</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Choroid Neoplasms</mesh_term>
<mesh_term>Uveitis</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000124
org study id: NEI-23
nct id: NCT00000124
lead sponsor:
To evaluate therapeutic interventions for patients who have choroidal melanoma, the most
common primary eye cancer affecting adults, and to assess the potential life-preserving as
well as sight-preserving role of radiation therapy.
To determine which of two standard treatments, removal of the eye or brachytherapy, is more
likely to prolong survival of eligible patients with medium-sized choroidal melanoma.
To determine whether preoperative radiation prolongs life for patients whose eyes with large
choroidal melanoma are enucleated.
For more than 100 years, removal of the eye (enucleation) has been the standard treatment for
choroidal melanoma. Before the COMS was initiated in 1986, interest in radiation therapy had
increased because of the potential for saving the eye and perhaps some vision. However, the
merits of radiation with respect to prolonging patient survival were unknown. The best data
from nonrandomized studies suggested that there was no difference in length of remaining life
between patients treated with radiation and those whose eyes were enucleated. Thus, it was
appropriate and necessary to conduct a randomized, controlled clinical trial in which a large
number of patients would be followed for many years in order to compare enucleation and
radiation with respect to relative success in prolonging survival of choroidal melanoma
patients.
The Collaborative Ocular Melanoma Study (COMS) is a set of long-term, multicenter, randomized
controlled trials. In the trial for patients with tumors of medium size, enucleation and
irradiation with an iodine-125 episcleral plaque are compared on the basis of length of
remaining life. All randomized patients will be followed for 5 to 15 years or until death.
For patients randomly assigned to enucleation, the eye was removed following a standard
procedure. For patients assigned to plaque irradiation, the margins of the tumor were located
and the dimensions of the tumor were measured by the ophthalmic surgeon. A gold plaque with a
plastic seed carrier that contained the proper dosage and configuration of radioactive iodine
seeds was sutured to the outside (sclera) of the eye over the base of the tumor. This
procedure made possible the delivery of a high dose of radiation to a very localized area (85
Gy [TG-43] to the tumor apex). The plaque typically was removed from the eye after three to
seven days. Enrollment was completed in this trial in July 1998 with 1,317 patients enrolled.
Clinical follow-up of patients will end in July 2003.
In the COMS trial of preoperative radiation, patients with large tumors were randomized to
enucleation alone or to enucleation preceded by 20 Gy of external beam radiation. The two
randomly assigned groups of patients were followed for at least five years or until death and
have been compared on the basis of length of remaining life and other outcomes. Enrollment in
this trial was completed in December 1994, with 1,003 patients enrolled. Clinical follow-up
of all patients in this trial ended in July 2000.
Accrual to a nonrandomized pilot study to assess the feasibility of a randomized trial for
small tumors was halted in 1989. Additional followup of those 204 patients was carried out
from 1994 to 1996.
The COMS is conducted in 43 clinical centers located in major population areas of the United
States and Canada. Six resource centers participate and have major roles in quality assurance
for the study. Information gathered and analyzed includes time to death from all causes, time
to death from cancer (whether metastatic choroidal melanoma or not), diagnosis of other
tumors, complications of radiation, and changes in visual acuity. A parallel study of quality
of life for patients enrolled in the trial of radioactive plaque was initiated in January
1995. From November 1986 through July 1998, 8,712 patients with choroidal melanoma of all
sizes were screened for eligibility for a COMS clinical trial.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Brachytherapy
intervention type: Procedure
intervention name: Eye Removal
criteria:
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/071201.asp
description: COMS Press Release July 12, 2001
url: http://www.nei.nih.gov/news/pressreleases/coms.asp
description: COMS Press Release June 15, 1998
citation: Byrne SF, Marsh MJ, Boldt HC, Green RL, Johnson RN, Wilson DJ. Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study COMS Report No. 13. Ophthalmic Epidemiol. 2002 Feb;9(1):11-27. doi: 10.1076/opep.9.1.11.1719.
PMID: 11815892
citation: Collaborative Ocular Melanoma Study Group. Sociodemographic and clinical predictors of participation in two randomized trials: findings from the Collaborative Ocular Melanoma Study COMS report no. 7. Control Clin Trials. 2001 Oct;22(5):526-37. doi: 10.1016/s0197-2456(01)00157-x.
PMID: 11578786
citation: Moy CS, Albert DM, Diener-West M, McCaffrey LD, Scully RE, Willson JK; Collaborative Ocular Melanoma Study Group, prepared by COMS Mortality Coding Committee. Cause-specific mortality coding. methods in the collaborative ocular melanoma study coms report no. 14. Control Clin Trials. 2001 Jun;22(3):248-62. doi: 10.1016/s0197-2456(01)00113-1.
PMID: 11384789
citation: Collaborative Ocular Melanoma Study Group.. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol. 2001 May;119(5):670-6. doi: 10.1001/archopht.119.5.670.
PMID: 11346394
citation: Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1.
PMID: 11158813
citation: Echography (Ultrasound) Procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part II. J Ophthalmic Nurs Technol. 1999 Sep-Oct;18(5):219-32. No abstract available.
PMID: 10847049
citation: Echography (ultrasound) procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part I. J Ophthalmic Nurs Technol. 1999 Jul-Aug;18(4):143-9. No abstract available.
PMID: 10847038
citation: Quality of life assessment in the collaborative ocular melanoma study: design and methods. COMS-QOLS Report No. 1. COMS Quality of Life Study Group. Ophthalmic Epidemiol. 1999 Mar;6(1):5-17. doi: 10.1076/opep.6.1.5.1565.
PMID: 10384680
citation: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.
PMID: 9744369
citation: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.
PMID: 9645716
citation: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma I: characteristics of patients enrolled and not enrolled. COMS report no. 9. Am J Ophthalmol. 1998 Jun;125(6):767-78. doi: 10.1016/s0002-9394(98)00038-5.
PMID: 9645715
citation: Histopathologic characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma Study. COMS report no. 6. Am J Ophthalmol. 1998 Jun;125(6):745-66. doi: 10.1016/s0002-9394(98)00040-3.
PMID: 9645714
citation: Factors predictive of growth and treatment of small choroidal melanoma: COMS Report No. 5. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Dec;115(12):1537-44. doi: 10.1001/archopht.1997.01100160707007.
PMID: 9400787
citation: Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR. Clear cell differentiation in choroidal melanoma. COMS report no. 8. Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):894-8. doi: 10.1001/archopht.1997.01100160064010.
PMID: 9230830
citation: Mortality in patients with small choroidal melanoma. COMS report no. 4. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):886-93.
PMID: 9230829
citation: Wells CG, Bradford RH, Fish GE, Straatsma BR, Hawkins BS. Choroidal melanomas in American Indians. COMS Group. Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1996 Aug;114(8):1017-8. doi: 10.1001/archopht.1996.01100140225024. No abstract available.
PMID: 8694711
citation: Design and methods of a clinical trial for a rare condition: the Collaborative Ocular Melanoma Study. COMS Report No. 3. Control Clin Trials. 1993 Oct;14(5):362-91. doi: 10.1016/0197-2456(93)90052-f.
PMID: 8222668
citation: Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS report no. 1. Arch Ophthalmol. 1990 Sep;108(9):1268-73. doi: 10.1001/archopht.1990.01070110084030. Erratum In: Arch Ophthalmol 1990 Dec;108(12):1708.
PMID: 2205183
citation: Earle J, Kline RW, Robertson DM. Selection of iodine 125 for the Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1987 Jun;105(6):763-4. doi: 10.1001/archopht.1987.01060060049030. No abstract available.
PMID: 3579705
citation: Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul;119(7):969-82. doi: 10.1001/archopht.119.7.969.
PMID: 11448319
citation: Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17. Arch Ophthalmol. 2001 Jul;119(7):951-65. doi: 10.1001/archopht.119.7.951.
PMID: 11448318
mesh term: Choroid Neoplasms
mesh term: Uveitis
|
NCT0000xxxx/NCT00000125.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000125</url>
</required_header>
<id_info>
<org_study_id>NEI-24</org_study_id>
<secondary_id>5U10EY009307-16</secondary_id>
<secondary_id>5U10EY009341-14</secondary_id>
<nct_id>NCT00000125</nct_id>
</id_info>
<brief_title>Ocular Hypertension Treatment Study (OHTS)</brief_title>
<acronym>OHTS</acronym>
<official_title>Ocular Hypertension Treatment Study (OHTS)</official_title>
<sponsors>
<lead_sponsor>
<agency>Washington University School of Medicine</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Washington University School of Medicine</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To determine whether medical reduction of intraocular pressure prevents or delays the onset
of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive
participants judged to be at moderate risk for developing open-angle glaucoma.

To produce natural history data to assist in identifying patients at most risk for developing
open-angle glaucoma and those most likely to benefit from early medical treatment.

To quantify risk factors for developing open-angle glaucoma among ocular hypertensive
individuals.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
OHTS Phase 3 will re-examine study participants 20 plus years after enrollment to document
clinical status and the incidence and severity of self-reported functional limitations. The
279 participants who developed POAG in OHTS Phase 1 or 2 will have more than 10 years of
post-POAG follow-up by Phase 3. The timing of re-examination at 20 years is meaningful
because 20 years approaches the median life expectancy of OHT patients in their 60's and 70's
and half the median life expectancy of patients in their 40's and 50's. For the first time,
patients with ocular hypertension and clinicians will have high quality data about the
long-term risk of developing POAG and functional limitations associated with the disease.
These data will facilitate patient-centered care so that patients and clinicians can decide
on the appropriate frequency of tests and examinations and the potential benefit of
preventative treatment.

Glaucoma is one of the leading causes of blindness in the United States and other
industrialized countries. It is estimated that 2 million people in the United States have
glaucoma and that 80,000 of these individuals are legally blind from the disease. Among
African Americans, glaucoma is now recognized as the leading cause of blindness.

Elevated intraocular pressure (IOP), a common condition affecting 3 to 6 million people in
the United States, is thought to be the leading risk factor for development of open-angle
glaucoma. There is no consensus that medical reduction of intraocular pressure prevents or
delays the onset of visual field and/or optic nerve damage in ocular hypertensive subjects.

Despite the lack of convincing evidence for the efficacy of medical treatment in ocular
hypertension, approximately 1.5 million glaucoma suspects in the United States are being
treated with costly ocular hypotensive medications that carry the potential for serious and
even life-threatening side effects.

Clearly, there is a need for a well-controlled clinical trial to determine whether medical
reduction of IOP can prevent or delay the onset of glaucomatous damage in ocular hypertensive
subjects. Only then can clinicians and patients make rational choices and health care
planners ensure that limited medical resources are being allocated in a safe and
cost-effective manner.

The Ocular Hypertension Treatment Study (OHTS) is a long-term, randomized, controlled
multicenter clinical trial. Ocular hypertensive subjects judged to be at moderate risk of
developing primary open-angle glaucoma are randomly assigned to either close observation only
or a stepped medical regimen. Medical treatment consists of all commercially available
topical ocular hypotensive eye drops.

After completion of baseline measures (IOP, visual fields, disc photos) and randomization,
the subjects are followed for a minimum of 5 years with automated threshold central static
perimetry (Humphrey program 30-2) twice yearly and stereoscopic optic disc photographs once
yearly. Study end points are reproducible visual field loss and/or progressive optic disc
damage in either eye of a patient attributed to glaucoma by a Masked Endpoint Committee. All
visual fields and optic disc photographs are read in a masked fashion in Reading Centers.

In the 1991 Baltimore Eye Survey, African Americans were shown to have a prevalence of
open-angle glaucoma four to five times higher than whites. Given this high prevalence of
glaucoma in the African American population, it is important to recruit and follow an
adequate sample of African American subjects in the trial (approximately 25 percent of the
total patient sample).

At the conclusion of this study, practitioners should be able to make reasonable estimates of
risk for individual ocular hypertensive patients and to determine which ocular hypertensive
individuals are most likely to benefit from early prophylactic medical treatment.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date type="Actual">February 1994</start_date>
<completion_date type="Actual">June 30, 2019</completion_date>
<primary_completion_date type="Actual">June 2002</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients</measure>
<time_frame>5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)</time_frame>
<description>Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">1636</enrollment>
<condition>Ocular Hypertension</condition>
<condition>Glaucoma</condition>
<arm_group>
<arm_group_label>Observation</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Close Observation.</description>
</arm_group>
<arm_group>
<arm_group_label>Treatment</arm_group_label>
<arm_group_type>Other</arm_group_type>
<description>Participants treated with commercially available topical ocular hypotensive eye drops.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Topical ocular hypotensive eye drops.</intervention_name>
<description>Topical ocular hypotensive eye drops.</description>
<arm_group_label>Treatment</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and nonpregnant women between the ages of 40 and 80 with IOP greater than or equal to
24 mm Hg but less than or equal to 32 mm Hg in at least one eye and IOP greater than or
equal to 21 but less than or equal to 32 mm Hg in the fellow eye, as well as normal visual
fields and optic discs are eligible for the trial. Patients presenting with best-corrected
visual acuity worse than 20/40 in either eye, previous intraocular surgery, a
life-threatening or debilitating disease, secondary causes of elevated IOP, angle-closure
glaucoma or anatomically narrow angles, other diseases that can cause visual field loss,
background diabetic retinopathy, optic disc abnormalities that can produce visual field
loss or obscure the interpretation of the optic disc, or unwillingness to undergo random
assignment are excluded from the trial.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Michael A Kass, MD</last_name>
<role>Study Chair</role>
<affiliation>Washington University Department of Ophthalmology and Visual Sciences</affiliation>
</overall_official>
<reference>
<citation>Gordon MO, Kass MA. The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol. 1999 May;117(5):573-83. doi: 10.1001/archopht.117.5.573.</citation>
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</reference>
<reference>
<citation>Gordon MO, Higginbotham EJ, Heuer DK, Parrish RK 2nd, Robin AL, Morris PA, Dunn DA, Wilson BS, Kass MA; Ocular Hypertension Treatment Study. Assessment of the Impact of an Endpoint Committee in the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2019 Mar;199:193-199. doi: 10.1016/j.ajo.2018.11.006. Epub 2018 Nov 22.</citation>
<PMID>30471242</PMID>
</reference>
<verification_date>May 2020</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>March 6, 2015</results_first_submitted>
<results_first_submitted_qc>March 6, 2015</results_first_submitted_qc>
<results_first_posted type="Estimate">March 19, 2015</results_first_posted>
<last_update_submitted>May 20, 2020</last_update_submitted>
<last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
<last_update_posted type="Actual">June 2, 2020</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Ocular Hypertension</mesh_term>
<mesh_term>Hypertension</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Antihypertensive Agents</mesh_term>
<mesh_term>Ophthalmic Solutions</mesh_term>
</intervention_browse>
<provided_document_section>
<provided_document>
<document_type>Informed Consent Form</document_type>
<document_has_protocol>No</document_has_protocol>
<document_has_icf>Yes</document_has_icf>
<document_has_sap>No</document_has_sap>
<document_date>February 6, 2019</document_date>
<document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT00000125/ICF_000.pdf</document_url>
</provided_document>
</provided_document_section>
<clinical_results>
<participant_flow>
<group_list>
<group group_id="P1">
<title>Observation</title>
<description>Close Observation</description>
</group>
<group group_id="P2">
<title>Treatment</title>
<description>Topical ocular hypotensive eye drops.</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="819"/>
<participants group_id="P2" count="817"/>
</participants_list>
</milestone>
<milestone>
<title>Completed OHTS Phase I, June 2002</title>
<participants_list>
<participants group_id="P1" count="706"/>
<participants group_id="P2" count="702"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="580">Completed OHTS Phase 2, through March 2009</participants>
<participants group_id="P2" count="579">Completed OHTS Phase 2, through March 2009</participants>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="239"/>
<participants group_id="P2" count="238"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<population>1636 ocular hypertensive patients were randomized to either close observation or ocular hypertensive medication.</population>
<group_list>
<group group_id="B1">
<title>Observation</title>
<description>Observation only</description>
</group>
<group group_id="B2">
<title>Treatment</title>
<description>Topical Antiglaucoma Agents: Topical Antiglaucoma Agents</description>
</group>
<group group_id="B3">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="819"/>
<count group_id="B2" value="817"/>
<count group_id="B3" value="1636"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>years</units>
<param>Mean</param>
<dispersion>Standard Deviation</dispersion>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="55.6" spread="9.7"/>
<measurement group_id="B2" value="55.2" spread="9.5"/>
<measurement group_id="B3" value="55.4" spread="9.6"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="346"/>
<measurement group_id="B2" value="359"/>
<measurement group_id="B3" value="705"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="473"/>
<measurement group_id="B2" value="458"/>
<measurement group_id="B3" value="931"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Race/Ethnicity, Customized</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>Native American</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="3"/>
<measurement group_id="B2" value="1"/>
<measurement group_id="B3" value="4"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>Asian</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="10"/>
<measurement group_id="B2" value="4"/>
<measurement group_id="B3" value="14"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>African American</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="205"/>
<measurement group_id="B2" value="203"/>
<measurement group_id="B3" value="408"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>Hispanic</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="35"/>
<measurement group_id="B2" value="24"/>
<measurement group_id="B3" value="59"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>White</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="560"/>
<measurement group_id="B2" value="577"/>
<measurement group_id="B3" value="1137"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>Other</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="6"/>
<measurement group_id="B2" value="8"/>
<measurement group_id="B3" value="14"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients</title>
<description>Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.</description>
<time_frame>5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)</time_frame>
<population>1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.</population>
<group_list>
<group group_id="O1">
<title>Observation</title>
<description>Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.</description>
</group>
<group group_id="O2">
<title>Treatment</title>
<description>Topical ocular hypotensive eye drops from February 1994 through March 2009.</description>
</group>
</group_list>
<measure>
<title>Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients</title>
<description>Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.</description>
<population>1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.</population>
<units>percent of participants</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="819"/>
<count group_id="O2" value="817"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<title>Incidence of glaucoma at 5 yr (OHTS I, June 2002)</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="9.5"/>
<measurement group_id="O2" value="4.4"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>Incidence of glaucoma 13 yr (OHTS II, March 2009)</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="20.0"/>
<measurement group_id="O2" value="14.1"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>Adverse events collected during OHTS I, from February 1994 to June 2002.</time_frame>
<desc>Specific ocular adverse events are unknown because adverse events were only collected with regard to organ system.</desc>
<group_list>
<group group_id="E1">
<title>Observation</title>
<description>Observation only from February 1994 to June 2002 .</description>
</group>
<group group_id="E2">
<title>Treatment</title>
<description>Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.</description>
</group>
</group_list>
<serious_events>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="12" subjects_at_risk="819"/>
<counts group_id="E2" subjects_affected="13" subjects_at_risk="817"/>
</event>
</event_list>
</category>
<category>
<title>Eye disorders</title>
<event_list>
<event>
<sub_title>Ocular Serious Adverse Events (OHTS I, June 2002)</sub_title>
<description>Specific ocular serious adverse events are unknown because they were only collected with regard to organ system.</description>
<counts group_id="E1" subjects_affected="12" subjects_at_risk="819"/>
<counts group_id="E2" subjects_affected="13" subjects_at_risk="817"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="481" subjects_at_risk="819"/>
<counts group_id="E2" subjects_affected="570" subjects_at_risk="817"/>
</event>
</event_list>
</category>
<category>
<title>Eye disorders</title>
<event_list>
<event>
<sub_title>Ocular Adverse Event (Not Serious)</sub_title>
<description>Adverse Events that were not serious.</description>
<counts group_id="E1" subjects_affected="481" subjects_at_risk="819"/>
<counts group_id="E2" subjects_affected="570" subjects_at_risk="817"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Michael Kass MD</name_or_title>
<organization>Washington University School of Medicine</organization>
<phone>314-362-5713</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000125
org study id: NEI-24
secondary id: 5U10EY009307-16
secondary id: 5U10EY009341-14
nct id: NCT00000125
lead sponsor:
collaborator:
has dmc: Yes
To determine whether medical reduction of intraocular pressure prevents or delays the onset
of glaucomatous visual field loss and/or optic disc damage in ocular hypertensive
participants judged to be at moderate risk for developing open-angle glaucoma.
To produce natural history data to assist in identifying patients at most risk for developing
open-angle glaucoma and those most likely to benefit from early medical treatment.
To quantify risk factors for developing open-angle glaucoma among ocular hypertensive
individuals.
OHTS Phase 3 will re-examine study participants 20 plus years after enrollment to document
clinical status and the incidence and severity of self-reported functional limitations. The
279 participants who developed POAG in OHTS Phase 1 or 2 will have more than 10 years of
post-POAG follow-up by Phase 3. The timing of re-examination at 20 years is meaningful
because 20 years approaches the median life expectancy of OHT patients in their 60's and 70's
and half the median life expectancy of patients in their 40's and 50's. For the first time,
patients with ocular hypertension and clinicians will have high quality data about the
long-term risk of developing POAG and functional limitations associated with the disease.
These data will facilitate patient-centered care so that patients and clinicians can decide
on the appropriate frequency of tests and examinations and the potential benefit of
preventative treatment.
Glaucoma is one of the leading causes of blindness in the United States and other
industrialized countries. It is estimated that 2 million people in the United States have
glaucoma and that 80,000 of these individuals are legally blind from the disease. Among
African Americans, glaucoma is now recognized as the leading cause of blindness.
Elevated intraocular pressure (IOP), a common condition affecting 3 to 6 million people in
the United States, is thought to be the leading risk factor for development of open-angle
glaucoma. There is no consensus that medical reduction of intraocular pressure prevents or
delays the onset of visual field and/or optic nerve damage in ocular hypertensive subjects.
Despite the lack of convincing evidence for the efficacy of medical treatment in ocular
hypertension, approximately 1.5 million glaucoma suspects in the United States are being
treated with costly ocular hypotensive medications that carry the potential for serious and
even life-threatening side effects.
Clearly, there is a need for a well-controlled clinical trial to determine whether medical
reduction of IOP can prevent or delay the onset of glaucomatous damage in ocular hypertensive
subjects. Only then can clinicians and patients make rational choices and health care
planners ensure that limited medical resources are being allocated in a safe and
cost-effective manner.
The Ocular Hypertension Treatment Study (OHTS) is a long-term, randomized, controlled
multicenter clinical trial. Ocular hypertensive subjects judged to be at moderate risk of
developing primary open-angle glaucoma are randomly assigned to either close observation only
or a stepped medical regimen. Medical treatment consists of all commercially available
topical ocular hypotensive eye drops.
After completion of baseline measures (IOP, visual fields, disc photos) and randomization,
the subjects are followed for a minimum of 5 years with automated threshold central static
perimetry (Humphrey program 30-2) twice yearly and stereoscopic optic disc photographs once
yearly. Study end points are reproducible visual field loss and/or progressive optic disc
damage in either eye of a patient attributed to glaucoma by a Masked Endpoint Committee. All
visual fields and optic disc photographs are read in a masked fashion in Reading Centers.
In the 1991 Baltimore Eye Survey, African Americans were shown to have a prevalence of
open-angle glaucoma four to five times higher than whites. Given this high prevalence of
glaucoma in the African American population, it is important to recruit and follow an
adequate sample of African American subjects in the trial (approximately 25 percent of the
total patient sample).
At the conclusion of this study, practitioners should be able to make reasonable estimates of
risk for individual ocular hypertensive patients and to determine which ocular hypertensive
individuals are most likely to benefit from early prophylactic medical treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients
time frame: 5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)
description: Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.
arm group label: Observation
arm group type: No Intervention
description: Close Observation.
arm group label: Treatment
arm group type: Other
description: Participants treated with commercially available topical ocular hypotensive eye drops.
intervention type: Drug
intervention name: Topical ocular hypotensive eye drops.
description: Topical ocular hypotensive eye drops.
arm group label: Treatment
criteria:
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael A Kass, MD
role: Study Chair
affiliation: Washington University Department of Ophthalmology and Visual Sciences
citation: Gordon MO, Kass MA. The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol. 1999 May;117(5):573-83. doi: 10.1001/archopht.117.5.573.
PMID: 10326953
citation: Keltner JL, Johnson CA, Quigg JM, Cello KE, Kass MA, Gordon MO. Confirmation of visual field abnormalities in the Ocular Hypertension Treatment Study. Ocular Hypertension Treatment Study Group. Arch Ophthalmol. 2000 Sep;118(9):1187-94. doi: 10.1001/archopht.118.9.1187.
PMID: 10980763
citation: Piltz J, Gross R, Shin DH, Beiser JA, Dorr DA, Kass MA, Gordon MO. Contralateral effect of topical beta-adrenergic antagonists in initial one-eyed trials in the ocular hypertension treatment study. Am J Ophthalmol. 2000 Oct;130(4):441-53. doi: 10.1016/s0002-9394(00)00527-4.
PMID: 11024416
citation: Brandt JD, Beiser JA, Kass MA, Gordon MO. Central corneal thickness in the Ocular Hypertension Treatment Study (OHTS). Ophthalmology. 2001 Oct;108(10):1779-88. doi: 10.1016/s0161-6420(01)00760-6.
PMID: 11581049
citation: Feuer WJ, Parrish RK 2nd, Schiffman JC, Anderson DR, Budenz DL, Wells MC, Hess DJ, Kass MA, Gordon MO. The Ocular Hypertension Treatment Study: reproducibility of cup/disk ratio measurements over time at an optic disc reading center. Am J Ophthalmol. 2002 Jan;133(1):19-28. doi: 10.1016/s0002-9394(01)01338-1.
PMID: 11755836
citation: Johnson CA, Keltner JL, Cello KE, Edwards M, Kass MA, Gordon MO, Budenz DL, Gaasterland DE, Werner E; Ocular Hypertension Study Group. Baseline visual field characteristics in the ocular hypertension treatment study. Ophthalmology. 2002 Mar;109(3):432-7. doi: 10.1016/s0161-6420(01)00948-4.
PMID: 11874743
citation: Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
PMID: 12049574
citation: Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
PMID: 12049575
citation: Keltner JL, Johnson CA, Cello KE, Edwards MA, Bandermann SE, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. Classification of visual field abnormalities in the ocular hypertension treatment study. Arch Ophthalmol. 2003 May;121(5):643-50. doi: 10.1001/archopht.121.5.643. Erratum In: Arch Ophthalmol. 2008 Apr;126(4):561.
PMID: 12742841
citation: Zangwill LM, Weinreb RN, Berry CC, Smith AR, Dirkes KA, Coleman AL, Piltz-Seymour JR, Liebmann JM, Cioffi GA, Trick G, Brandt JD, Gordon MO, Kass MA; Confocal Scanning Laser Ophthalmoscopy Ancillary Study to the Ocular Hypertension Treatment Study. Racial differences in optic disc topography: baseline results from the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study. Arch Ophthalmol. 2004 Jan;122(1):22-8. doi: 10.1001/archopht.122.1.22.
PMID: 14718290
citation: Zangwill LM, Weinreb RN, Berry CC, Smith AR, Dirkes KA, Liebmann JM, Brandt JD, Trick G, Cioffi GA, Coleman AL, Piltz-Seymour JR, Gordon MO, Kass MA; OHTS CSLO Ancillary Study Group. The confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study: study design and baseline factors. Am J Ophthalmol. 2004 Feb;137(2):219-27. doi: 10.1016/j.ajo.2003.08.031.
PMID: 14962409
citation: Higginbotham EJ, Gordon MO, Beiser JA, Drake MV, Bennett GR, Wilson MR, Kass MA; Ocular Hypertension Treatment Study Group. The Ocular Hypertension Treatment Study: topical medication delays or prevents primary open-angle glaucoma in African American individuals. Arch Ophthalmol. 2004 Jun;122(6):813-20. doi: 10.1001/archopht.122.6.813.
PMID: 15197055
citation: Coleman AL, Gordon MO, Beiser JA, Kass MA; Ocular Hypertension Treatment Study. Baseline risk factors for the development of primary open-angle glaucoma in the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2004 Oct;138(4):684-5. doi: 10.1016/j.ajo.2004.05.030.
PMID: 15488816
citation: Brandt JD, Beiser JA, Gordon MO, Kass MA; Ocular Hypertension Treatment Study (OHTS) Group. Central corneal thickness and measured IOP response to topical ocular hypotensive medication in the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2004 Nov;138(5):717-22. doi: 10.1016/j.ajo.2004.07.036.
PMID: 15531304
citation: Kass MA, Gordon MO, Kymes SM. Incorporating the results of the Ocular Hypertension Treatment Study into clinical practice. Arch Ophthalmol. 2005 Jul;123(7):1021-2. doi: 10.1001/archopht.123.7.1021-b. No abstract available.
PMID: 16009857
citation: Zangwill LM, Weinreb RN, Beiser JA, Berry CC, Cioffi GA, Coleman AL, Trick G, Liebmann JM, Brandt JD, Piltz-Seymour JR, Dirkes KA, Vega S, Kass MA, Gordon MO. Baseline topographic optic disc measurements are associated with the development of primary open-angle glaucoma: the Confocal Scanning Laser Ophthalmoscopy Ancillary Study to the Ocular Hypertension Treatment Study. Arch Ophthalmol. 2005 Sep;123(9):1188-97. doi: 10.1001/archopht.123.9.1188.
PMID: 16157798
citation: Keltner JL, Johnson CA, Levine RA, Fan J, Cello KE, Kass MA, Gordon MO. Normal visual field test results following glaucomatous visual field end points in the Ocular Hypertension Treatment Study. Arch Ophthalmol. 2005 Sep;123(9):1201-6. doi: 10.1001/archopht.123.9.1201.
PMID: 16157799
citation: Parrish RK 2nd, Schiffman JC, Feuer WJ, Anderson DR, Budenz DL, Wells-Albornoz MC, Vandenbroucke R, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. Test-retest reproducibility of optic disk deterioration detected from stereophotographs by masked graders. Am J Ophthalmol. 2005 Oct;140(4):762-4. doi: 10.1016/j.ajo.2005.04.044.
PMID: 16226544
citation: Kymes SM, Kass MA, Anderson DR, Miller JP, Gordon MO; Ocular Hypertension Treatment Study Group (OHTS). Management of ocular hypertension: a cost-effectiveness approach from the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2006 Jun;141(6):997-1008. doi: 10.1016/j.ajo.2006.01.019.
PMID: 16765666
citation: Levine RA, Demirel S, Fan J, Keltner JL, Johnson CA, Kass MA; Ocular Hypertension Treatment Study Group. Asymmetries and visual field summaries as predictors of glaucoma in the ocular hypertension treatment study. Invest Ophthalmol Vis Sci. 2006 Sep;47(9):3896-903. doi: 10.1167/iovs.05-0469.
PMID: 16936102
citation: Keltner JL, Johnson CA, Anderson DR, Levine RA, Fan J, Cello KE, Quigley HA, Budenz DL, Parrish RK, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. The association between glaucomatous visual fields and optic nerve head features in the Ocular Hypertension Treatment Study. Ophthalmology. 2006 Sep;113(9):1603-12. doi: 10.1016/j.ophtha.2006.05.061.
PMID: 16949445
citation: Herman DC, Gordon MO, Beiser JA, Chylack LT Jr, Lamping KA, Schein OD, Soltau JB, Kass MA; Ocular Hypertension Treatment Study (OHTS) Group. Topical ocular hypotensive medication and lens opacification: evidence from the ocular hypertension treatment study. Am J Ophthalmol. 2006 Nov;142(5):800-10. doi: 10.1016/j.ajo.2006.06.052.
PMID: 17056362
citation: Budenz DL, Anderson DR, Feuer WJ, Beiser JA, Schiffman J, Parrish RK 2nd, Piltz-Seymour JR, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. Detection and prognostic significance of optic disc hemorrhages during the Ocular Hypertension Treatment Study. Ophthalmology. 2006 Dec;113(12):2137-43. doi: 10.1016/j.ophtha.2006.06.022. Epub 2006 Sep 25.
PMID: 16996592
citation: Ocular Hypertension Treatment Study Group; European Glaucoma Prevention Study Group; Gordon MO, Torri V, Miglior S, Beiser JA, Floriani I, Miller JP, Gao F, Adamsons I, Poli D, D'Agostino RB, Kass MA. Validated prediction model for the development of primary open-angle glaucoma in individuals with ocular hypertension. Ophthalmology. 2007 Jan;114(1):10-9. doi: 10.1016/j.ophtha.2006.08.031. Epub 2006 Nov 7.
PMID: 17095090
citation: Mansberger SL, Hughes BA, Gordon MO, Spaner SD, Beiser JA, Cioffi GA, Kass MA; Ocular Hypertension Treatment Study Group. Comparison of initial intraocular pressure response with topical beta-adrenergic antagonists and prostaglandin analogues in African American and white individuals in the Ocular Hypertension Treatment Study. Arch Ophthalmol. 2007 Apr;125(4):454-9. doi: 10.1001/archopht.125.4.454.
PMID: 17420364
citation: Keltner JL, Johnson CA, Cello KE, Bandermann SE, Fan J, Levine RA, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. Visual field quality control in the Ocular Hypertension Treatment Study (OHTS). J Glaucoma. 2007 Dec;16(8):665-9. doi: 10.1097/IJG.0b013e318057526d.
PMID: 18091452
citation: Gordon MO, Beiser JA, Kass MA; Ocular Hypertension Treatment Study Group. Is a history of diabetes mellitus protective against developing primary open-angle glaucoma? Arch Ophthalmol. 2008 Feb;126(2):280-1. doi: 10.1001/archophthalmol.2007.35. No abstract available.
PMID: 18268230
citation: Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. Diabetes and glaucoma. Arch Ophthalmol. 2008 May;126(5):746-7. doi: 10.1001/archopht.126.5.746-b. No abstract available.
PMID: 18474807
citation: Brandt JD, Gordon MO, Beiser JA, Lin SC, Alexander MY, Kass MA; Ocular Hypertension Treatment Study Group. Changes in central corneal thickness over time: the ocular hypertension treatment study. Ophthalmology. 2008 Sep;115(9):1550-6, 1556.e1. doi: 10.1016/j.ophtha.2008.02.001. Epub 2008 Apr 18.
PMID: 18378313
citation: Ocular Hypertension Treatment Study Group and the European Glaucoma Prevention Study Group. The accuracy and clinical application of predictive models for primary open-angle glaucoma in ocular hypertensive individuals. Ophthalmology. 2008 Nov;115(11):2030-6. doi: 10.1016/j.ophtha.2008.06.036. Epub 2008 Sep 18.
PMID: 18801578
citation: Bhorade AM, Gordon MO, Wilson B, Weinreb RN, Kass MA; Ocular Hypertension Treatment Study Group. Variability of intraocular pressure measurements in observation participants in the ocular hypertension treatment study. Ophthalmology. 2009 Apr;116(4):717-24. doi: 10.1016/j.ophtha.2008.12.036. Epub 2009 Feb 25. Erratum In: Ophthalmology. 2009 May;116(5):822. Weinrab, Robert N [corrected to Weinreb, Robert N].
PMID: 19243824
citation: Barnett EM, Fantin A, Wilson BS, Kass MA, Gordon MO; Ocular Hypertension Treatment Study Group. The incidence of retinal vein occlusion in the ocular hypertension treatment study. Ophthalmology. 2010 Mar;117(3):484-8. doi: 10.1016/j.ophtha.2009.08.022. Epub 2010 Jan 19.
PMID: 20031222
citation: Kymes SM, Plotzke MR, Kass MA, Boland MV, Gordon MO. Effect of patient's life expectancy on the cost-effectiveness of treatment for ocular hypertension. Arch Ophthalmol. 2010 May;128(5):613-8. doi: 10.1001/archophthalmol.2010.83.
PMID: 20457984
citation: Weinreb RN, Zangwill LM, Jain S, Becerra LM, Dirkes K, Piltz-Seymour JR, Cioffi GA, Trick GL, Coleman AL, Brandt JD, Liebmann JM, Gordon MO, Kass MA; OHTS CSLO Ancillary Study Group. Predicting the onset of glaucoma: the confocal scanning laser ophthalmoscopy ancillary study to theOcular Hypertension Treatment Study. Ophthalmology. 2010 Sep;117(9):1674-83. doi: 10.1016/j.ophtha.2010.03.044. Epub 2010 Jul 14.
PMID: 20633931
citation: Bhorade AM, Wilson BS, Gordon MO, Palmberg P, Weinreb RN, Miller E, Chang RT, Kass MA; Ocular Hypertension Treatment Study Group. The utility of the monocular trial: data from the ocular hypertension treatment study. Ophthalmology. 2010 Nov;117(11):2047-54. doi: 10.1016/j.ophtha.2010.02.020. Epub 2010 Aug 12.
PMID: 20619460
citation: Artes PH, Chauhan BC, Keltner JL, Cello KE, Johnson CA, Anderson DR, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. Longitudinal and cross-sectional analyses of visual field progression in participants of the Ocular Hypertension Treatment Study. Arch Ophthalmol. 2010 Dec;128(12):1528-32. doi: 10.1001/archophthalmol.2010.292.
PMID: 21149774
citation: Gao F, Miller JP, Xiong C, Beiser JA, Gordon M; The Ocular Hypertension Treatment Study (OHTS) Group. A joint-modeling approach to assess the impact of biomarker variability on the risk of developing clinical outcome. Stat Methods Appt. 2011 Mar 1;20(1):83-100. doi: 10.1007/s10260-010-0150-z.
PMID: 21339862
citation: Gao F, Miller JP, Miglior S, Beiser JA, Torri V, Kass MA, Gordon MO. A Joint Model for Prognostic Effect of Biomarker Variability on Outcomes: long-term intraocular pressure (IOP) fluctuation on the risk of developing primary open-angle glaucoma (POAG). JP J Biostat. 2011 May 1;5(2):73-96.
PMID: 22180704
citation: Gordon MO, Gao F, Beiser JA, Miller JP, Kass MA. The 10-year incidence of glaucoma among patients with treated and untreated ocular hypertension. Arch Ophthalmol. 2011 Dec;129(12):1630-1. doi: 10.1001/archophthalmol.2011.337. No abstract available.
PMID: 22159688
citation: Demirel S, De Moraes CG, Gardiner SK, Liebmann JM, Cioffi GA, Ritch R, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. The rate of visual field change in the ocular hypertension treatment study. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):224-7. doi: 10.1167/iovs.10-7117.
PMID: 22159015
citation: Brandt JD, Gordon MO, Gao F, Beiser JA, Miller JP, Kass MA; Ocular Hypertension Treatment Study Group. Adjusting intraocular pressure for central corneal thickness does not improve prediction models for primary open-angle glaucoma. Ophthalmology. 2012 Mar;119(3):437-42. doi: 10.1016/j.ophtha.2011.03.018. Epub 2011 Jun 25.
PMID: 21705084
citation: De Moraes CG, Demirel S, Gardiner SK, Liebmann JM, Cioffi GA, Ritch R, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. Effect of treatment on the rate of visual field change in the ocular hypertension treatment study observation group. Invest Ophthalmol Vis Sci. 2012 Apr 2;53(4):1704-9. doi: 10.1167/iovs.11-8186.
PMID: 22395889
citation: Kymes SM, Lambert DL, Lee PP, Musch DC, Siegfried CJ, Kotak SV, Stwalley DL, Fain J, Johnson C, Gordon MO. The development of a decision analytic model of changes in mean deviation in people with glaucoma: the COA model. Ophthalmology. 2012 Jul;119(7):1367-74. doi: 10.1016/j.ophtha.2012.01.054. Epub 2012 Apr 25.
PMID: 22537616
citation: Mansberger SL, Gordon MO, Jampel H, Bhorade A, Brandt JD, Wilson B, Kass MA; Ocular Hypertension Treatment Study Group. Reduction in intraocular pressure after cataract extraction: the Ocular Hypertension Treatment Study. Ophthalmology. 2012 Sep;119(9):1826-31. doi: 10.1016/j.ophtha.2012.02.050. Epub 2012 May 16.
PMID: 22608478
citation: Gardiner SK, Demirel S, De Moraes CG, Liebmann JM, Cioffi GA, Ritch R, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. Series length used during trend analysis affects sensitivity to changes in progression rate in the ocular hypertension treatment study. Invest Ophthalmol Vis Sci. 2013 Feb 15;54(2):1252-9. doi: 10.1167/iovs.12-10218.
PMID: 23349433
citation: Zangwill LM, Jain S, Dirkes K, He F, Medeiros FA, Trick GL, Brandt JD, Cioffi GA, Coleman AL, Liebmann JM, Piltz-Seymour JR, Gordon MO, Kass MA, Weinreb RN; Confocal Scanning Laser Ophthalmoscopy Ancillary Study to the Ocular Hypertension Treatment Study. The rate of structural change: the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study. Am J Ophthalmol. 2013 Jun;155(6):971-82. doi: 10.1016/j.ajo.2013.01.020. Epub 2013 Mar 14.
PMID: 23497845
citation: Gardiner SK, Demirel S, Gordon MO, Kass MA; Ocular Hypertension Treatment Study Group. Seasonal changes in visual field sensitivity and intraocular pressure in the ocular hypertension treatment study. Ophthalmology. 2013 Apr;120(4):724-30. doi: 10.1016/j.ophtha.2012.09.056. Epub 2013 Jan 26.
PMID: 23357622
citation: De Moraes CG, Demirel S, Gardiner SK, Liebmann JM, Cioffi GA, Ritch R, Gordon MO, Kass MA. Rate of visual field progression in eyes with optic disc hemorrhages in the ocular hypertension treatment study. Arch Ophthalmol. 2012 Dec;130(12):1541-6. doi: 10.1001/jamaophthalmol.2013.1137.
PMID: 23229692
citation: Baratz KH, Nau CB, Winter EJ, McLaren JW, Hodge DO, Herman DC, Bourne WM. Effects of glaucoma medications on corneal endothelium, keratocytes, and subbasal nerves among participants in the ocular hypertension treatment study. Cornea. 2006 Oct;25(9):1046-52. doi: 10.1097/01.ico.0000230499.07273.c5.
PMID: 17133051
citation: Savatovsky E, Mwanza JC, Budenz DL, Feuer WJ, Vandenbroucke R, Schiffman JC, Anderson DR; Ocular Hypertension Treatment Study. Longitudinal changes in peripapillary atrophy in the ocular hypertension treatment study: a case-control assessment. Ophthalmology. 2015 Jan;122(1):79-86. doi: 10.1016/j.ophtha.2014.07.033. Epub 2014 Sep 7.
PMID: 25208858
citation: Christopher M, Abramoff MD, Tang L, Gordon MO, Kass MA, Budenz DL, Fingert JH, Scheetz TE. Stereo Photo Measured ONH Shape Predicts Development of POAG in Subjects With Ocular Hypertension. Invest Ophthalmol Vis Sci. 2015 Jul;56(8):4470-9. doi: 10.1167/iovs.14-16142.
PMID: 26193923
citation: Gao F, Miller JP, Beiser JA, Xiong C, Gordon MO. Predicting Clinical Binary Outcome Using Multivariate Longitudinal Data: Application to Patients with Newly Diagnosed Primary Open-Angle Glaucoma. J Biom Biostat. 2015 Oct;6(4):254. doi: 10.4172/2155-6180.1000254. Epub 2015 Oct 26.
PMID: 26904374
citation: Schaefer JL, Lukowski ZL, Meyer AM, Leoncavallo AJ, Greer A, Martorana GM, Zou B, Shuster JJ, Sherwood MB. Comparing Glaucomatous Disc Change Using Stereo Disc Viewing and the MatchedFlicker Software Program in Ophthalmologists-in-Training. Am J Ophthalmol. 2016 Jul;167:88-95. doi: 10.1016/j.ajo.2016.03.031. Epub 2016 Mar 31.
PMID: 27038890
citation: Scheetz TE, Faga B, Ortega L, Roos BR, Gordon MO, Kass MA, Wang K, Fingert JH. Glaucoma Risk Alleles in the Ocular Hypertension Treatment Study. Ophthalmology. 2016 Dec;123(12):2527-2536. doi: 10.1016/j.ophtha.2016.08.036. Epub 2016 Oct 1.
PMID: 27707548
citation: Khawaja AP, Cooke Bailey JN, Kang JH, Allingham RR, Hauser MA, Brilliant M, Budenz DL, Christen WG, Fingert J, Gaasterland D, Gaasterland T, Kraft P, Lee RK, Lichter PR, Liu Y, Medeiros F, Moroi SE, Richards JE, Realini T, Ritch R, Schuman JS, Scott WK, Singh K, Sit AJ, Vollrath D, Wollstein G, Zack DJ, Zhang K, Pericak-Vance M, Weinreb RN, Haines JL, Pasquale LR, Wiggs JL. Assessing the Association of Mitochondrial Genetic Variation With Primary Open-Angle Glaucoma Using Gene-Set Analyses. Invest Ophthalmol Vis Sci. 2016 Sep 1;57(11):5046-5052. doi: 10.1167/iovs.16-20017.
PMID: 27661856
citation: Bailey JN, Loomis SJ, Kang JH, Allingham RR, Gharahkhani P, Khor CC, Burdon KP, Aschard H, Chasman DI, Igo RP Jr, Hysi PG, Glastonbury CA, Ashley-Koch A, Brilliant M, Brown AA, Budenz DL, Buil A, Cheng CY, Choi H, Christen WG, Curhan G, De Vivo I, Fingert JH, Foster PJ, Fuchs C, Gaasterland D, Gaasterland T, Hewitt AW, Hu F, Hunter DJ, Khawaja AP, Lee RK, Li Z, Lichter PR, Mackey DA, McGuffin P, Mitchell P, Moroi SE, Perera SA, Pepper KW, Qi Q, Realini T, Richards JE, Ridker PM, Rimm E, Ritch R, Ritchie M, Schuman JS, Scott WK, Singh K, Sit AJ, Song YE, Tamimi RM, Topouzis F, Viswanathan AC, Verma SS, Vollrath D, Wang JJ, Weisschuh N, Wissinger B, Wollstein G, Wong TY, Yaspan BL, Zack DJ, Zhang K, Study EN; ANZRAG Consortium; Weinreb RN, Pericak-Vance MA, Small K, Hammond CJ, Aung T, Liu Y, Vithana EN, MacGregor S, Craig JE, Kraft P, Howell G, Hauser MA, Pasquale LR, Haines JL, Wiggs JL. Genome-wide association analysis identifies TXNRD2, ATXN2 and FOXC1 as susceptibility loci for primary open-angle glaucoma. Nat Genet. 2016 Feb;48(2):189-94. doi: 10.1038/ng.3482. Epub 2016 Jan 11.
PMID: 26752265
citation: Budenz DL, Huecker JB, Gedde SJ, Gordon M, Kass M; Ocular Hypertension Treatment Study Group. Thirteen-Year Follow-up of Optic Disc Hemorrhages in the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2017 Feb;174:126-133. doi: 10.1016/j.ajo.2016.10.023. Epub 2016 Nov 7.
PMID: 27832941
citation: Schaefer JL, Meyer AM, Rodgers CD, Rosenberg NC, Leoncavallo AJ, Lukowski ZL, Greer AB, Martorana GM, Zou B, Shuster JJ, Jay Katz L, Schuman JS, Kass MA, Sherwood MB. Comparing glaucomatous disc change using stereo disc viewing and the MatchedFlicker programme in glaucoma experts and trainees. Br J Ophthalmol. 2018 Mar;102(3):358-363. doi: 10.1136/bjophthalmol-2017-310336. Epub 2017 Aug 16.
PMID: 28814418
citation: Gao F, Philip Miller J, Xiong C, Luo J, Beiser JA, Chen L, Gordon MO. Estimating correlation between multivariate longitudinal data in the presence of heterogeneity. BMC Med Res Methodol. 2017 Aug 17;17(1):124. doi: 10.1186/s12874-017-0398-1.
PMID: 28818061
citation: Chen Z, Wang K. A gene-based test of association through an orthogonal decomposition of genotype scores. Hum Genet. 2017 Oct;136(10):1385-1394. doi: 10.1007/s00439-017-1839-y. Epub 2017 Sep 1.
PMID: 28864915
citation: Wang K. Conditional asymptotic inference for the kernel association test. Bioinformatics. 2017 Dec 1;33(23):3733-3739. doi: 10.1093/bioinformatics/btx511.
PMID: 28961861
citation: Gordon MO, Kass MA. What We Have Learned From the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2018 May;189:xxiv-xxvii. doi: 10.1016/j.ajo.2018.02.016. Epub 2018 Mar 1.
PMID: 29501371
citation: Gordon MO, Higginbotham EJ, Heuer DK, Parrish RK 2nd, Robin AL, Morris PA, Dunn DA, Wilson BS, Kass MA; Ocular Hypertension Treatment Study. Assessment of the Impact of an Endpoint Committee in the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2019 Mar;199:193-199. doi: 10.1016/j.ajo.2018.11.006. Epub 2018 Nov 22.
PMID: 30471242
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
mesh term: Hypertension
mesh term: Antihypertensive Agents
mesh term: Ophthalmic Solutions
provided document:
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000126.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000126</url>
</required_header>
<id_info>
<org_study_id>NEI-25</org_study_id>
<nct_id>NCT00000126</nct_id>
</id_info>
<brief_title>Ischemic Optic Neuropathy Decompression Trial Followup (IONDT Followup)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial
(IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in
the second eye, (2) changes in visual acuity over time in both the study and second eye, and
(3) other aspects of the natural history of NAION.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
NAION is the most common cause of acute optic nerve disease in the elderly, causing permanent
and severe visual loss. No proven treatment currently exists to reverse or arrest this loss.
There is no accepted method for the prevention or reduction of the likelihood of second eye
involvement. NAION strikes both eyes in as many as 40 percent of affected patients (Beri et
al. 1987), with a 2-year risk of about 25 percent (Steven Feldon, personal communication to
SEK).

IONDT compared optic nerve decompression surgery (ONDS), which was becoming a widely used
treatment for NAION, with careful followup alone, in patients with newly diagnosed NAION. The
rationale for the surgery was that NAION was caused by impaired blood flow to the optic nerve
and that decompression surgery would restore vision by alleviating pressure surrounding the
nerve. Because ONDS was fast becoming the standard of care, evaluation of the safety and
efficacy of the procedure was tested in the context of a randomized clinical trial.

Within 2 years of the start of the IONDT, the Data and Safety Monitoring Committee
recommended cessation of the clinical trial recruitment. The National Institutes of Health
issued a clinical alert to 25,000 ophthalmologists and neurologists describing the study
findings that surgery was no better than careful followup and may be harmful (IONDT 1995). It
was recommended that ONDS not be used in cases of NAION. Thus, the IONDT findings not only
have led to a costly and ineffective surgery to be abandoned as a treatment for NAION, but
also have left practitioners with a dearth of treatment choices.

The IONDT is the first multicenter, prospective study of newly diagnosed patients with NAION.
The baseline history and examination, which took place within 14 days of the onset of
symptoms, used standardized methods and diagnostic criteria to collect data on all factors
possibly relating to the etiology of NAION. In reports from previous studies that present
data on both initial and final visual acuities, no data are available regarding change in
visual acuity over time for individual patients. Where data are available on final visual
acuity, reported rates of improvement are low, ranging from 0 percent to 33 percent for
untreated eyes. The IONDT found, however, an improvement of three or more lines in 42.7
percent of patients who received careful followup.

NAION in both eyes has been reported in as few as 10.5 percent and as many as 73 percent of
patients. In a study of bilateral NAION where all patients were prospectively logged, Beri et
al. reported that 17.5 percent of patients developed bilateral disease at 1 year of followup
and 34.5 percent developed it at 5 years. However, Beck et al., using a life table analysis
on the same cohort reported by Beri et al., estimated the risk of bilateral NAION to be 12
percent within 2 years and 19 percent within 5 years. The IONDT has so far similarly reported
a 12 percent (25/216) incidence of bilateral NAION in its randomized patients. The incidence
in the nonrandomized group, 91 percent of whom had visual acuity better than 20/64, is much
lower at 4 percent (5/136).

Thus, continued followup of the IONDT cohort is critically important to ascertain a clear
picture of the natural history of NAION in terms of involvement of the second eye and
long-term vision. Data obtained will be critical in understanding the etiology of the disease
and in generating hypotheses for testing further treatments for the disease.

The IONDT Followup Study will continue to monitor vision and other health outcomes in
patients originally enrolled in the IONDT, whether randomized to one of the two treatment
groups or whether followed as part of the natural history cohort. All IONDT patients were
diagnosed with NAION within 14 days of onset of symptoms, have had a minimum of 2 years of
continuous followup, and will be followed for an additional 4 years in the Followup Study.
Patients will have annual visits at the original IONDT Clinical Center or, if necessary, with
a surrogate provider. If NAION occurs in the second eye, the patient will be asked to visit
the clinic for a special visit. The Coordinating Center will telephone the patients on a
quarterly basis, between annual visits. Outcomes that will be examined include:

- incidence of NAION in the second eye,

- medical or ocular events surrounding the occurrence of NAION,

- visual acuity (measured using the New York Lighthouse charts).

In the event of an NAION event in the second eye, the patient's visual field will be tested
by using the Humphrey Perimeter.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>October 1994</start_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<time_perspective>Other</time_perspective>
</study_design_info>
<condition>Ischemic Optic Neuropathy</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Surgery</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
All living patients from the 420 patients originally enrolled in the IONDT have been asked
to participate in the IONDT Followup Study. No new patients are being recruited.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Doheny Eye Institute, University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jules Stein Eye Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, University of California, San Francisco</name>
<address>
<city>San Francisco</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, University of Florida</name>
<address>
<city>Gainesville</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory Eye Center, Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, University of Illinois</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, University of Kentucky</name>
<address>
<city>Lexington</city>
<state>Kentucky</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Maryland</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>W.K. Kellogg Eye Center, University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Michigan State University</name>
<address>
<city>East Lansing</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>William Beaumont Eye Institute, William Beaumont Hospital</name>
<address>
<city>Royal Oak</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mason Institute of Ophthalmology, University of Missouri - Columbia</name>
<address>
<city>Columbia</city>
<state>Missouri</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Louis University, Anheuser-Busch Eye Institute</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY Health Science Center, Department of Neurology</name>
<address>
<city>Syracuse</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Carolinas Medical Center</name>
<address>
<city>Charlotte</city>
<state>North Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Cleveland Clinic Foundation</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Allegheny General Hospital</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Carolina, Department of Ophthalmology</name>
<address>
<city>Columbia</city>
<state>South Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas</name>
<address>
<city>Houston</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Utah, Department of Ophthalmology</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Virginia, Department of Ophthalmology</name>
<address>
<city>Charlottesville</city>
<state>Virginia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medical College of Virginia, Department of Neurology</name>
<address>
<city>Richmond</city>
<state>Virginia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>West Virginia University, Department of Neurology</name>
<address>
<city>Morgantown</city>
<state>West Virginia</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>May 25, 2006</last_update_submitted>
<last_update_submitted_qc>May 25, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">May 26, 2006</last_update_posted>
<keyword>Non-arteritic Ischemic Optic Neuropathy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Optic Nerve Diseases</mesh_term>
<mesh_term>Optic Neuropathy, Ischemic</mesh_term>
<mesh_term>Ischemia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000126
org study id: NEI-25
nct id: NCT00000126
lead sponsor:
To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial
(IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in
the second eye, (2) changes in visual acuity over time in both the study and second eye, and
(3) other aspects of the natural history of NAION.
NAION is the most common cause of acute optic nerve disease in the elderly, causing permanent
and severe visual loss. No proven treatment currently exists to reverse or arrest this loss.
There is no accepted method for the prevention or reduction of the likelihood of second eye
involvement. NAION strikes both eyes in as many as 40 percent of affected patients (Beri et
al. 1987), with a 2-year risk of about 25 percent (Steven Feldon, personal communication to
SEK).
IONDT compared optic nerve decompression surgery (ONDS), which was becoming a widely used
treatment for NAION, with careful followup alone, in patients with newly diagnosed NAION. The
rationale for the surgery was that NAION was caused by impaired blood flow to the optic nerve
and that decompression surgery would restore vision by alleviating pressure surrounding the
nerve. Because ONDS was fast becoming the standard of care, evaluation of the safety and
efficacy of the procedure was tested in the context of a randomized clinical trial.
Within 2 years of the start of the IONDT, the Data and Safety Monitoring Committee
recommended cessation of the clinical trial recruitment. The National Institutes of Health
issued a clinical alert to 25,000 ophthalmologists and neurologists describing the study
findings that surgery was no better than careful followup and may be harmful (IONDT 1995). It
was recommended that ONDS not be used in cases of NAION. Thus, the IONDT findings not only
have led to a costly and ineffective surgery to be abandoned as a treatment for NAION, but
also have left practitioners with a dearth of treatment choices.
The IONDT is the first multicenter, prospective study of newly diagnosed patients with NAION.
The baseline history and examination, which took place within 14 days of the onset of
symptoms, used standardized methods and diagnostic criteria to collect data on all factors
possibly relating to the etiology of NAION. In reports from previous studies that present
data on both initial and final visual acuities, no data are available regarding change in
visual acuity over time for individual patients. Where data are available on final visual
acuity, reported rates of improvement are low, ranging from 0 percent to 33 percent for
untreated eyes. The IONDT found, however, an improvement of three or more lines in 42.7
percent of patients who received careful followup.
NAION in both eyes has been reported in as few as 10.5 percent and as many as 73 percent of
patients. In a study of bilateral NAION where all patients were prospectively logged, Beri et
al. reported that 17.5 percent of patients developed bilateral disease at 1 year of followup
and 34.5 percent developed it at 5 years. However, Beck et al., using a life table analysis
on the same cohort reported by Beri et al., estimated the risk of bilateral NAION to be 12
percent within 2 years and 19 percent within 5 years. The IONDT has so far similarly reported
a 12 percent (25/216) incidence of bilateral NAION in its randomized patients. The incidence
in the nonrandomized group, 91 percent of whom had visual acuity better than 20/64, is much
lower at 4 percent (5/136).
Thus, continued followup of the IONDT cohort is critically important to ascertain a clear
picture of the natural history of NAION in terms of involvement of the second eye and
long-term vision. Data obtained will be critical in understanding the etiology of the disease
and in generating hypotheses for testing further treatments for the disease.
The IONDT Followup Study will continue to monitor vision and other health outcomes in
patients originally enrolled in the IONDT, whether randomized to one of the two treatment
groups or whether followed as part of the natural history cohort. All IONDT patients were
diagnosed with NAION within 14 days of onset of symptoms, have had a minimum of 2 years of
continuous followup, and will be followed for an additional 4 years in the Followup Study.
Patients will have annual visits at the original IONDT Clinical Center or, if necessary, with
a surrogate provider. If NAION occurs in the second eye, the patient will be asked to visit
the clinic for a special visit. The Coordinating Center will telephone the patients on a
quarterly basis, between annual visits. Outcomes that will be examined include:
- incidence of NAION in the second eye,
- medical or ocular events surrounding the occurrence of NAION,
- visual acuity (measured using the New York Lighthouse charts).
In the event of an NAION event in the second eye, the patient's visual field will be tested
by using the Humphrey Perimeter.
time perspective: Other
intervention type: Procedure
intervention name: Surgery
criteria:
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
mesh term: Optic Nerve Diseases
mesh term: Optic Neuropathy, Ischemic
mesh term: Ischemia
|
NCT0000xxxx/NCT00000127.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000127</url>
</required_header>
<id_info>
<org_study_id>NEI-26</org_study_id>
<nct_id>NCT00000127</nct_id>
</id_info>
<brief_title>Ischemic Optic Neuropathy Decompression Trial (IONDT)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To assess the safety and efficacy of optic nerve sheath decompression surgery for
non-arteritic ischemic optic neuropathy (NAION).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Non-arteritic ischemic optic neuropathy (NAION), the most common cause of acute optic nerve
disease in older persons, causes permanent and severe visual loss. Visual function can be
impaired through decreased central visual acuity or peripheral field loss, or both. NAION
strikes both eyes in up to 40 percent of affected patients. The incidence of NAION has been
estimated at 2.3 per 100,000 persons over the age of 50 years and 0.54 per 100,000 for all
ages. Estimates of the number of new cases seen each year in the United States range from a
low of approximately 1,500 to a high of 6,000.

NAION has been hypothesized to be caused by vascular insufficiency leading to optic nerve
head ischemia. There is general agreement that NAION results from transient non-perfusion of
nutrient vessels. The wide range of visual field defects and visual loss with NAION can be
explained by the extent and number of the blood vessels involved.

Anatomical factors appear to contribute to the vascular event initiating NAION. Clinically,
the number of discs congenitally lacking a physiological cup in eyes with NAION is higher
than expected. Presumably, in eyes with NAION, these discs have small scleral openings that
crowd the nerve fibers as they pass through the restricted space in the optic disc and lamina
cribrosa, thereby predisposing to an ischemic spiral.

One current theory holds that NAION begins as a minor ischemic event that later progresses to
a major infarction due to congenitally anomalous optic nerves. The inciting ischemic event
leads to local anterior nerve edema, and this causes further ischemia.

Optic nerve sheath decompression surgery was reported in 1989 to be of benefit to patients
with NAION. The presumed mechanism of action in optic nerve decompression surgery revolved
around restoration of impaired blood flow to the optic nerve through reduction of the
pressure around the nerve.

The Ischemic Optic Neuropathy Decompression Trial (IONDT) was a randomized clinical trial
designed to compare the improvements in visual acuity at 6 months in patients assigned to
receive surgery with optic nerve sheath decompression with those assigned to careful
followup. A cohort of patients, with a baseline visual acuity of better than 20/64 are also
being followed to better understand the natural history of the disease, including second eye
involvement.

Enrollment began in October 1992. Randomization was stratified by clinic, and patients had an
equal probability of assignment to surgery or careful followup. All patients are being
followed for a minimum of 2 years.

The primary outcome is a change of three lines or more in visual acuity at the 6-month
followup visit compared with visual acuity measured at the randomization visit.

Secondary outcomes include a change in visual acuity beyond 6 months, change in peripheral
visual function as measured by automated Humphrey perimetry, local and systemic side effects
from treatment, change in quality of life, and other associated morbidity and mortality.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>October 1992</start_date>
<completion_date type="Actual">October 1994</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Ischemic Optic Neuropathy</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Optic Nerve Sheath Decompression Surgery</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women age 50 years or older, with acute NAION and visual symptoms for 14 days or
less since the onset of symptoms, and visual acuity worse than or equal to 20/64 were
eligible for randomization.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-iondt.asp</url>
<description>Clinical Alert to Ophthalmologists and Neurologists</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/iondtpressrelease.asp</url>
<description>NEI Press Release-Eye Surgery Found Ineffective and May be Harmful -- Study Halted</description>
</link>
<reference>
<citation>The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials. 1998 Jun;19(3):276-96. doi: 10.1016/s0197-2456(98)00003-8.</citation>
<PMID>9620811</PMID>
</reference>
<reference>
<citation>Characteristics of patients with nonarteritic anterior ischemic optic neuropathy eligible for the Ischemic Optic Neuropathy Decompression Trial. Arch Ophthalmol. 1996 Nov;114(11):1366-74. doi: 10.1001/archopht.1996.01100140566007.</citation>
<PMID>8906027</PMID>
</reference>
<reference>
<citation>Scherer RW; Crawley B; Abstracts for the Ischemic Optic Neuropathy Study Group; Responses to ethical and other questions on a knowledge assessment form for a multicenter trial. [Abstract]., Controlled Clinical Trials 1993;14:442S</citation>
</reference>
<reference>
<citation>Crawley B; Scherer RW; Ischemic Optic Neuropathy Decompression Trial (IONDT): Participation in the IONDT. Race, gender and age. [Abstract]., Controlled Clinical Trials 1994;15:102S</citation>
</reference>
<reference>
<citation>Crawley B; Waring MT; Scherer RW; Coordinating Center for the Ischemic Optic Neuropathy Decompression Trial (IONDT): IONDT tracking system: Where is form 2034 for patient ICMORE and who is responsible? [Abstract]., Controlled Clinical Trials 1994;15:93S</citation>
</reference>
<reference>
<citation>Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32.</citation>
<PMID>7844872</PMID>
</reference>
<reference>
<citation>Kaufman D; Ischemic Optic Neuropathy Decompression Trial Study Group; Optic nerve decompression surgery for nonarteritic ischemic optic neuropathy (NAION is not effective and could be harmful: Results of the Ischemic Optic Neuropathy Decompression Trial (IONDT). [Abstract]., Invest Ophthalmol Vis Sci 1995;36:S196</citation>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>March 23, 2010</last_update_submitted>
<last_update_submitted_qc>March 23, 2010</last_update_submitted_qc>
<last_update_posted type="Estimate">March 24, 2010</last_update_posted>
<keyword>Non-arteritic Ischemic Optic Neuropathy</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Optic Nerve Diseases</mesh_term>
<mesh_term>Optic Neuropathy, Ischemic</mesh_term>
<mesh_term>Ischemia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000127
org study id: NEI-26
nct id: NCT00000127
lead sponsor:
To assess the safety and efficacy of optic nerve sheath decompression surgery for
non-arteritic ischemic optic neuropathy (NAION).
Non-arteritic ischemic optic neuropathy (NAION), the most common cause of acute optic nerve
disease in older persons, causes permanent and severe visual loss. Visual function can be
impaired through decreased central visual acuity or peripheral field loss, or both. NAION
strikes both eyes in up to 40 percent of affected patients. The incidence of NAION has been
estimated at 2.3 per 100,000 persons over the age of 50 years and 0.54 per 100,000 for all
ages. Estimates of the number of new cases seen each year in the United States range from a
low of approximately 1,500 to a high of 6,000.
NAION has been hypothesized to be caused by vascular insufficiency leading to optic nerve
head ischemia. There is general agreement that NAION results from transient non-perfusion of
nutrient vessels. The wide range of visual field defects and visual loss with NAION can be
explained by the extent and number of the blood vessels involved.
Anatomical factors appear to contribute to the vascular event initiating NAION. Clinically,
the number of discs congenitally lacking a physiological cup in eyes with NAION is higher
than expected. Presumably, in eyes with NAION, these discs have small scleral openings that
crowd the nerve fibers as they pass through the restricted space in the optic disc and lamina
cribrosa, thereby predisposing to an ischemic spiral.
One current theory holds that NAION begins as a minor ischemic event that later progresses to
a major infarction due to congenitally anomalous optic nerves. The inciting ischemic event
leads to local anterior nerve edema, and this causes further ischemia.
Optic nerve sheath decompression surgery was reported in 1989 to be of benefit to patients
with NAION. The presumed mechanism of action in optic nerve decompression surgery revolved
around restoration of impaired blood flow to the optic nerve through reduction of the
pressure around the nerve.
The Ischemic Optic Neuropathy Decompression Trial (IONDT) was a randomized clinical trial
designed to compare the improvements in visual acuity at 6 months in patients assigned to
receive surgery with optic nerve sheath decompression with those assigned to careful
followup. A cohort of patients, with a baseline visual acuity of better than 20/64 are also
being followed to better understand the natural history of the disease, including second eye
involvement.
Enrollment began in October 1992. Randomization was stratified by clinic, and patients had an
equal probability of assignment to surgery or careful followup. All patients are being
followed for a minimum of 2 years.
The primary outcome is a change of three lines or more in visual acuity at the 6-month
followup visit compared with visual acuity measured at the randomization visit.
Secondary outcomes include a change in visual acuity beyond 6 months, change in peripheral
visual function as measured by automated Humphrey perimetry, local and systemic side effects
from treatment, change in quality of life, and other associated morbidity and mortality.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Optic Nerve Sheath Decompression Surgery
criteria:
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/clinicalalerts/alert-iondt.asp
description: Clinical Alert to Ophthalmologists and Neurologists
url: http://www.nei.nih.gov/news/pressreleases/iondtpressrelease.asp
description: NEI Press Release-Eye Surgery Found Ineffective and May be Harmful -- Study Halted
citation: The ischemic optic neuropathy decompression trial (IONDT): design and methods. Control Clin Trials. 1998 Jun;19(3):276-96. doi: 10.1016/s0197-2456(98)00003-8.
PMID: 9620811
citation: Characteristics of patients with nonarteritic anterior ischemic optic neuropathy eligible for the Ischemic Optic Neuropathy Decompression Trial. Arch Ophthalmol. 1996 Nov;114(11):1366-74. doi: 10.1001/archopht.1996.01100140566007.
PMID: 8906027
citation: Scherer RW; Crawley B; Abstracts for the Ischemic Optic Neuropathy Study Group; Responses to ethical and other questions on a knowledge assessment form for a multicenter trial. [Abstract]., Controlled Clinical Trials 1993;14:442S
citation: Crawley B; Scherer RW; Ischemic Optic Neuropathy Decompression Trial (IONDT): Participation in the IONDT. Race, gender and age. [Abstract]., Controlled Clinical Trials 1994;15:102S
citation: Crawley B; Waring MT; Scherer RW; Coordinating Center for the Ischemic Optic Neuropathy Decompression Trial (IONDT): IONDT tracking system: Where is form 2034 for patient ICMORE and who is responsible? [Abstract]., Controlled Clinical Trials 1994;15:93S
citation: Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32.
PMID: 7844872
citation: Kaufman D; Ischemic Optic Neuropathy Decompression Trial Study Group; Optic nerve decompression surgery for nonarteritic ischemic optic neuropathy (NAION is not effective and could be harmful: Results of the Ischemic Optic Neuropathy Decompression Trial (IONDT). [Abstract]., Invest Ophthalmol Vis Sci 1995;36:S196
mesh term: Optic Nerve Diseases
mesh term: Optic Neuropathy, Ischemic
mesh term: Ischemia
|
NCT0000xxxx/NCT00000128.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000128</url>
</required_header>
<id_info>
<org_study_id>NEI-27</org_study_id>
<nct_id>NCT00000128</nct_id>
</id_info>
<brief_title>A Trial of Bifocals in Myopic Children With Esophoria</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To test the hypothesis that correction with bifocal spectacle lenses rather than
single-vision lenses will slow the progression of myopia in children with near-point
esophoria. The primary outcome variable is cycloplegic refraction as measured with an
automated refractor. Axial length is measured with ultrasound in order to test the corollary
hypothesis that use of bifocals will slow ocular growth in these myopic children. We will
also examine the amount of close work performed by subjects and the degree of parental myopia
as factors that may influence myopia progression.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
About 25 percent of all persons in the United States are myopic. The most common form of
myopia is childhood myopia, which begins after age 6 and progresses rapidly until age 16.
Myopia progression results from excessive growth of the eye, primarily by enlargement of the
vitreous chamber. Excessive elongation of the eye is a major risk factor for retinal
detachment.

Previous prospective studies failed to show that use of bifocals was effective in slowing
myopia progression. However, these studies did not separate subjects by near-point phoria
before randomization. Retrospective studies by David Goss indicated that bifocals slowed
myopia progression by almost 50 percent in children with near-point esophoria but had no
effect on children with exophoria.

A small, prospective pilot study, completed by the investigators of this trial, also
supported the hypothesis that bifocals slow myopia progression in children with near-point
esophoria. Thirty-two myopic children, all of whom showed near-point esophoria, were enrolled
in this 18-month study. Twenty-eight children completed the study, with 14 randomized into
bifocals and 14 into single-vision lenses. Cycloplegic automated refraction was performed
every 6 months. Over the course of the whole study, there was a small, statistically
insignificant difference in the rates of myopia progression: 0.57 diopters per year (D/yr)
(S.E. = 0.11) for those in single-vision lenses compared with 0.36 D/yr (S.E. = 0.12) for
those in bifocals (p = 0.26).

However, significant seasonal effects in myopia progression were demonstrated, and the
results also suggested that the beneficial effects of bifocals may take several months to
develop. During the first 6 months, which included most of the school year, myopia
progression was rapid in both the bifocal group (0.61 D/yr) and the single-vision group (0.68
D/yr). During the second 6 months, which included all of the summer vacation, myopia
progression was slow in both groups, 0.32 and 0.26 D/yr for bifocal wearers and single-vision
wearers, respectively. During the last 6 months, i.e., the second school year, myopia
progressed slowly in the bifocal wearers (0.37 D/yr) but rapidly (0.80 D/yr) in single-vision
wearers. A repeated-measure analysis of variance demonstrated a significant seasonal effect
(p < 0.002) and a significant interaction between season and type of correction (p < 0.043).

The apparent effectiveness of bifocals in children with near-point esophoria and the lack of
effectiveness in other children may be explained by a greater lag of accommodation in
children with esophoria. This lag might cause a slightly blurred retinal image that the
bifocal may sharpen. Other mechanisms might also be involved.

Eighty or more myopic children, all with near-point esophoria as measured at baseline with
von Graefe prisms through a current myopic correction placed in a phoropter, will be randomly
assigned to wear either single-vision spectacle lenses or lenses with +1.50 D add in a
flat-top 28-mm segment. Subjects will visit one of two sites, either a private optometry
practice in Tulsa or the optometry clinic at Northeastern State University, every 6 months.
Data collected at each visit will include automated refraction after cycloplegia with 1
percent tropicamide, biometry with A-scan, and estimates of the amount of study and other
close work by means of questionnaires administered to the subjects and their parents. We will
also obtain measures of the degree of myopia in the biological parents. The myopic correction
will be changed if the spherical component of the refraction in either eye has changed by 0.5
diopter or more or if any change in cylinder power or axis improves vision in either eye by
three letters or more. The study will continue for 30 months and will include six visits by
each subject.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>June 1996</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Myopia</condition>
<condition>Strabismus</condition>
<condition>Esophoria</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Bifocal Spectacle Lenses</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Boys must have been between 6 and 12 years of age; girls between 6 and 11 years of age. All
children must have had at least 0.5 diopters of myopia in both eyes, near-point esophoria,
at least 20/25 acuity in each eye, and 40 seconds of stereopsis and must have been free of
ocular disease or systemic disease that may have altered refraction. All subjects were
willing to wear bifocal spectacle lenses for 30 months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>12 Years</maximum_age>
</eligibility>
<reference>
<citation>Fulk GW, Cyert LA. Can bifocals slow myopia progression? J Am Optom Assoc. 1996 Dec;67(12):749-54.</citation>
<PMID>9286316</PMID>
</reference>
<reference>
<citation>Fulk GW; Cyert LA; Parker DE; A 3-year clinical trial of bifocals to slow myopia progression in children with near-point esophoria: Baseline characteristics., Invest Ophthalmol Vis Sci 1997;38(4):S1158</citation>
</reference>
<reference>
<citation>Fulk GW, Cyert LA, Parker DE. A randomized trial of the effect of single-vision vs. bifocal lenses on myopia progression in children with esophoria. Optom Vis Sci. 2000 Aug;77(8):395-401. doi: 10.1097/00006324-200008000-00006.</citation>
<PMID>10966065</PMID>
</reference>
<verification_date>June 2002</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Near-point Esophoria</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Strabismus</mesh_term>
<mesh_term>Esotropia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000128
org study id: NEI-27
nct id: NCT00000128
lead sponsor:
To test the hypothesis that correction with bifocal spectacle lenses rather than
single-vision lenses will slow the progression of myopia in children with near-point
esophoria. The primary outcome variable is cycloplegic refraction as measured with an
automated refractor. Axial length is measured with ultrasound in order to test the corollary
hypothesis that use of bifocals will slow ocular growth in these myopic children. We will
also examine the amount of close work performed by subjects and the degree of parental myopia
as factors that may influence myopia progression.
About 25 percent of all persons in the United States are myopic. The most common form of
myopia is childhood myopia, which begins after age 6 and progresses rapidly until age 16.
Myopia progression results from excessive growth of the eye, primarily by enlargement of the
vitreous chamber. Excessive elongation of the eye is a major risk factor for retinal
detachment.
Previous prospective studies failed to show that use of bifocals was effective in slowing
myopia progression. However, these studies did not separate subjects by near-point phoria
before randomization. Retrospective studies by David Goss indicated that bifocals slowed
myopia progression by almost 50 percent in children with near-point esophoria but had no
effect on children with exophoria.
A small, prospective pilot study, completed by the investigators of this trial, also
supported the hypothesis that bifocals slow myopia progression in children with near-point
esophoria. Thirty-two myopic children, all of whom showed near-point esophoria, were enrolled
in this 18-month study. Twenty-eight children completed the study, with 14 randomized into
bifocals and 14 into single-vision lenses. Cycloplegic automated refraction was performed
every 6 months. Over the course of the whole study, there was a small, statistically
insignificant difference in the rates of myopia progression: 0.57 diopters per year (D/yr)
(S.E. = 0.11) for those in single-vision lenses compared with 0.36 D/yr (S.E. = 0.12) for
those in bifocals (p = 0.26).
However, significant seasonal effects in myopia progression were demonstrated, and the
results also suggested that the beneficial effects of bifocals may take several months to
develop. During the first 6 months, which included most of the school year, myopia
progression was rapid in both the bifocal group (0.61 D/yr) and the single-vision group (0.68
D/yr). During the second 6 months, which included all of the summer vacation, myopia
progression was slow in both groups, 0.32 and 0.26 D/yr for bifocal wearers and single-vision
wearers, respectively. During the last 6 months, i.e., the second school year, myopia
progressed slowly in the bifocal wearers (0.37 D/yr) but rapidly (0.80 D/yr) in single-vision
wearers. A repeated-measure analysis of variance demonstrated a significant seasonal effect
(p < 0.002) and a significant interaction between season and type of correction (p < 0.043).
The apparent effectiveness of bifocals in children with near-point esophoria and the lack of
effectiveness in other children may be explained by a greater lag of accommodation in
children with esophoria. This lag might cause a slightly blurred retinal image that the
bifocal may sharpen. Other mechanisms might also be involved.
Eighty or more myopic children, all with near-point esophoria as measured at baseline with
von Graefe prisms through a current myopic correction placed in a phoropter, will be randomly
assigned to wear either single-vision spectacle lenses or lenses with +1.50 D add in a
flat-top 28-mm segment. Subjects will visit one of two sites, either a private optometry
practice in Tulsa or the optometry clinic at Northeastern State University, every 6 months.
Data collected at each visit will include automated refraction after cycloplegia with 1
percent tropicamide, biometry with A-scan, and estimates of the amount of study and other
close work by means of questionnaires administered to the subjects and their parents. We will
also obtain measures of the degree of myopia in the biological parents. The myopic correction
will be changed if the spherical component of the refraction in either eye has changed by 0.5
diopter or more or if any change in cylinder power or axis improves vision in either eye by
three letters or more. The study will continue for 30 months and will include six visits by
each subject.
allocation: Randomized
primary purpose: Treatment
intervention type: Device
intervention name: Bifocal Spectacle Lenses
criteria:
gender: All
minimum age: 6 Years
maximum age: 12 Years
citation: Fulk GW, Cyert LA. Can bifocals slow myopia progression? J Am Optom Assoc. 1996 Dec;67(12):749-54.
PMID: 9286316
citation: Fulk GW; Cyert LA; Parker DE; A 3-year clinical trial of bifocals to slow myopia progression in children with near-point esophoria: Baseline characteristics., Invest Ophthalmol Vis Sci 1997;38(4):S1158
citation: Fulk GW, Cyert LA, Parker DE. A randomized trial of the effect of single-vision vs. bifocal lenses on myopia progression in children with esophoria. Optom Vis Sci. 2000 Aug;77(8):395-401. doi: 10.1097/00006324-200008000-00006.
PMID: 10966065
mesh term: Strabismus
mesh term: Esotropia
|
NCT0000xxxx/NCT00000129.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000129</url>
</required_header>
<id_info>
<org_study_id>NEI-28</org_study_id>
<nct_id>NCT00000129</nct_id>
</id_info>
<brief_title>Prospective Evaluation of Radial Keratotomy (PERK) Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether radial keratotomy is effective in reducing myopia.

To detect complications of the surgery.

To discover patient characteristics and surgical factors affecting the results.

To determine the long-term safety and efficacy of the procedure.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Approximately 11 million Americans have myopia that can be corrected with eyeglasses or
contact lenses. Some of these people may also be candidates for radial keratotomy (RK), a
procedure that aims to correct or reduce myopia by surgery that flattens the corneal
curvature.

Keratotomy was first performed by surgeons in Europe and the United States in the late 1800s,
and the basic optical and mechanical principles of the operation were defined in the 1940s
and 1950s by the Japanese doctors T. Sato and K. Akiyama, who used anterior and posterior
corneal incisions. The posterior incisions damaged the cornea, and the procedure was modified
in the Soviet Union by doctors Fyodorov and V. Durnev to include incisions in only the
anterior cornea. Since its introduction into the United States in 1978, numerous
ophthalmologists have modified the procedure by introducing technical and surgical
improvements such as ultrasonic methods to measure the thickness of the cornea and the use of
diamond-bladed micrometer knives to make the incisions.

However, scientific assessment of RK lagged behind growing public and professional interest
in the procedure. In 1980, in response to widespread concern about the long-term safety and
efficacy of RK, a group of ophthalmic surgeons approached the National Eye Institute with a
proposal for a multicenter clinical trial that would evaluate the potential benefits and
risks of this procedure.

The Prospective Evaluation of Radial Keratotomy study, involving 435 patients and 99 pilot
patients, was a clinical trial designed to evaluate the short- and long-term safety and
efficacy of one technique of radial keratotomy. The procedure was evaluated by comparing a
patient's refractive error and uncorrected vision before and after surgery. The more myopic
eye received surgery first. Patients were required to wait 1 year before having the operation
on the second eye.

The surgical technique was standardized, consisting of eight centrifugal radial incisions
made manually with a diamond micrometer knife. The diameter of the central, uncut, clear zone
was determined by the preoperative spherical equivalent cycloplegic refraction (-2.00 to
-3.12 D = 4.0 mm; -3.25 to -4.3 D = 3.5 mm; -4.50 to -8.00 D = 3.0 mm). The blade length,
which determined the depth of the incision, was set at 100 percent of the thinnest of four
intraoperative ultrasonic corneal thickness readings taken paracentrally at the 3-, 6-, 9-,
and 12-o'clock meridians just outside the mark delineating the clear zone. The incisions were
made from the edge of the trephine mark to the limbal vascular arcade and were spaced
equidistantly around the cornea.

Patients were examined preoperatively and after surgery at 2 weeks, 3 months, 6 months,
annually for 5 years, and at 10 years. Examinations in the morning and evening of the same
day were done at 3 months, 1 year, 3 years, and 11 years in a subset of the patients to test
for diurnal fluctuation of vision and refraction.

The primary outcome variables measured at each visit was the uncorrected and
spectacle-corrected visual acuity and the refractive error with the pupil dilated and
undilated. The corneal shape was measured with central keratometry and photokeratoscopy.
Endothelial function was evaluated using specular microscopy. A slit-lamp microscope
examination was made to check for complications from the incisions. Contrast sensitivity was
tested in a subset of patients. Patient motivation and satisfaction were studied with
psychometric questionnaires at baseline, 1 year, 5-6 years, and 10 years.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>April 1981</start_date>
<completion_date type="Actual">October 1983</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Myopia</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Radial Keratotomy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
All men and women had 2 to 8 diopters of simple myopia and were correctable to 20/20 or
better with glasses or contact lenses. All patients had the stability of their myopia
documented by previous records. Patients were at least 21 years of age and lived in the
metropolitan area of the study centers. Each patient agreed to have surgery on one eye and
to wait 1 year for surgery on the other eye. Patients with systemic diseases that might
affect corneal wound healing and patients with high corneal astigmatism were excluded from
the study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/perkpressrelease.asp</url>
<description>NEI Press Release-Ten-Year Results on Radial Keratotomy Released</description>
</link>
<reference>
<citation>Waring GO 3rd, Moffitt SD, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, Safir A, Schanzlin DJ, Bourque LB. Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1983 Jan;90(1):40-58. doi: 10.1016/s0161-6420(83)34603-0.</citation>
<PMID>6338438</PMID>
</reference>
<reference>
<citation>Bourque LB, Rubenstein R, Cosand B, Waring GO 3rd, Moffitt S, Gelender H, Laibson PR, Lindstrom RL, McDonald M, Myers WD, et al. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study. Arch Ophthalmol. 1984 Aug;102(8):1187-92. doi: 10.1001/archopht.1984.01040030965027.</citation>
<PMID>6380467</PMID>
</reference>
<reference>
<citation>Novak AF; Lindstrom RL; Williams PA; Everson M; Corneal pachymetry prior to radial keratotomy: a comparison of techniques., J Refract Surg 1985;1:151-153</citation>
</reference>
<reference>
<citation>Steinberg EB, Waring GO 3rd. Comparison of two methods of marking the visual axis on the cornea during radial keratotomy. Am J Ophthalmol. 1983 Nov;96(5):605-8. doi: 10.1016/s0002-9394(14)73417-8.</citation>
<PMID>6638126</PMID>
</reference>
<reference>
<citation>Steinberg EB, Wilson LA, Waring GO 3rd, Lynn MJ, Coles WH. Stellate iron lines in the corneal epithelium after radial keratotomy. Am J Ophthalmol. 1984 Oct 15;98(4):416-21. doi: 10.1016/0002-9394(84)90122-3.</citation>
<PMID>6486212</PMID>
</reference>
<reference>
<citation>Nelson JD, Williams P, Lindstrom RL, Doughman DJ. Map-fingerprint-dot changes in the corneal epithelial basement membrane following radial keratotomy. Ophthalmology. 1985 Feb;92(2):199-205. doi: 10.1016/s0161-6420(85)34055-1.</citation>
<PMID>3872431</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, McDonald MB, Schanzlin DJ, et al. Results of the prospective evaluation of radial keratotomy (PERK) study one year after surgery. Ophthalmology. 1985 Feb;92(2):177-98, 307. doi: 10.1016/s0161-6420(85)34054-x.</citation>
<PMID>3885128</PMID>
</reference>
<reference>
<citation>Atkin A, Asbell P, Justin N, Smith H, Wayne R, Winterkorn J. Radial keratotomy and glare effects on contrast sensitivity. Doc Ophthalmol. 1986 Feb 28;62(2):129-48. doi: 10.1007/BF00229125.</citation>
<PMID>3956364</PMID>
</reference>
<reference>
<citation>Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986 Mar;104(3):356-63. doi: 10.1001/archopht.1986.01050150056026.</citation>
<PMID>3954634</PMID>
</reference>
<reference>
<citation>Bourque LB; Cosand BB; Drews C; Waring GO; Lynn M; Cartwright C; Satisfaccion informada, fluctuacion de la vision y resplandor en pacientes al cabo de un ano tras la cirugia en el estudio de la evaluacion prospectiva de la queratotomia radial (EPQR)., Arch Ophthalmol 1986;2:57-64</citation>
</reference>
<reference>
<citation>Mandelbaum S, Waring GO 3rd, Forster RK, Culbertson WW, Rowsey JJ, Espinal ME. Late development of ulcerative keratitis in radial keratotomy scars. Arch Ophthalmol. 1986 Aug;104(8):1156-60. doi: 10.1001/archopht.1986.01050200062050.</citation>
<PMID>3741245</PMID>
</reference>
<reference>
<citation>Schanzlin DJ, Santos VR, Waring GO 3rd, Lynn M, Bourque L, Cantillo N, Edwards MA, Justin N, Reinig J, Roszka-Duggan V. Diurnal change in refraction, corneal curvature, visual acuity, and intraocular pressure after radial keratotomy in the PERK Study. Ophthalmology. 1986 Feb;93(2):167-75. doi: 10.1016/s0161-6420(86)33765-5.</citation>
<PMID>3951823</PMID>
</reference>
<reference>
<citation>Villasenor RA, Santos VR, Cox KC, Harris DF 2nd, Lynn M, Waring GO 3rd. Comparison of ultrasonic corneal thickness measurements before and during surgery in the prospective evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1986 Mar;93(3):327-30. doi: 10.1016/s0161-6420(86)33746-1.</citation>
<PMID>3517739</PMID>
</reference>
<reference>
<citation>Lynn MJ; Waring GO; Predictability and stability of radial keratotomy., J. Refract Surg 1987;3:193-196</citation>
</reference>
<reference>
<citation>Lynn MJ, Waring GO 3rd, Sperduto RD. Factors affecting outcome and predictability of radial keratotomy in the PERK Study. Arch Ophthalmol. 1987 Jan;105(1):42-51. doi: 10.1001/archopht.1987.01060010048030.</citation>
<PMID>3800746</PMID>
</reference>
<reference>
<citation>Santos VR, Waring GO 3rd, Lynn MJ, Holladay JT, Sperduto RD. Relationship between refractive error and visual acuity in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1987 Jan;105(1):86-92. doi: 10.1001/archopht.1987.01060010092038.</citation>
<PMID>3800751</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, Culbertson W, Laibson PR, Lindstrom RD, McDonald MB, Myers WD, Obstbaum SA, Rowsey JJ, Schanzlin DJ. Three-year results of the Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1987 Oct;94(10):1339-54. doi: 10.1016/s0161-6420(87)80021-0.</citation>
<PMID>3684210</PMID>
</reference>
<reference>
<citation>Cartwright CS, Bourque LB, Lynn M, Waring GO 3rd. Relationship of glare to uncorrected visual acuity and cycloplegic refraction 1 year after radial keratotomy in the prospective evaluation of radial keratotomy (PERK) study. J Am Optom Assoc. 1988 Jan;59(1):36-9.</citation>
<PMID>3278044</PMID>
</reference>
<reference>
<citation>McDonnell PJ, Schanzlin DJ. Early changes in refractive error following radial keratotomy. Arch Ophthalmol. 1988 Feb;106(2):212-4. doi: 10.1001/archopht.1988.01060130222031.</citation>
<PMID>3341977</PMID>
</reference>
<reference>
<citation>Rowsey JJ, Balyeat HD, Monlux R, Holladay J, Waring GO 3rd, Lynn MJ. Prospective evaluation of radial keratotomy. Photokeratoscope corneal topography. Ophthalmology. 1988 Mar;95(3):322-34. doi: 10.1016/s0161-6420(88)33179-9.</citation>
<PMID>3174000</PMID>
</reference>
<reference>
<citation>Santos VR, Waring GO 3rd, Lynn MJ, Schanzlin DJ, Cantillo N, Espinal ME, Garbus J, Justin N, Roszka-Duggan V. Morning-to-evening change in refraction, corneal curvature, and visual acuity 2 to 4 years after radial keratotomy in the PERK Study. Ophthalmology. 1988 Nov;95(11):1487-93. doi: 10.1016/s0161-6420(88)32981-7.</citation>
<PMID>3211457</PMID>
</reference>
<reference>
<citation>Serle JB, Asbell PA, Obstbaum SA, Podos SM, Anh-Le N. The evaluation of corneal endothelial permeability in PERK study patients. Br J Ophthalmol. 1988 Apr;72(4):274-7. doi: 10.1136/bjo.72.4.274.</citation>
<PMID>3378023</PMID>
</reference>
<reference>
<citation>Lynn MJ, Waring GO 3rd, Nizam A, Kutner MH, Culbertson W, McDonald MB, Meyers WD, Naidoff MA, Nelson JD, Obstbaum SA, et al. Symmetry of refractive and visual acuity outcome in the Prospective Evaluation of Radial Keratotomy (PERK) study. Refract Corneal Surg. 1989 Mar-Apr;5(2):75-81.</citation>
<PMID>2488790</PMID>
</reference>
<reference>
<citation>Rowsey JJ, Monlux R, Balyeat HD, Stevens SX, Gelender H, Holladay J, Krachmer JH, Laibson P, Lindstrom R, Lynn M, et al. Accuracy and reproducibility of KeraScanner analysis in PERK corneal topography. PERK Study Group. Curr Eye Res. 1989 Jul;8(7):661-74. doi: 10.3109/02713688909025800.</citation>
<PMID>2791617</PMID>
</reference>
<reference>
<citation>Ginsburg AP, Waring GO 3rd, Steinberg EB, Williams PA, Justin N, Deitz JR, Roszka-Duggan VK, Baluvelt K, Bourque L. Contrast sensitivity under photopic conditions in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Refract Corneal Surg. 1990 Mar-Apr;6(2):82-91.</citation>
<PMID>2248920</PMID>
</reference>
<reference>
<citation>Lynn MJ, Waring GO 3rd, Carter JT. Combining refractive error and uncorrected visual acuity to assess the effectiveness of refractive corneal surgery. Refract Corneal Surg. 1990 Mar-Apr;6(2):103-9; discussion 109-12.</citation>
<PMID>2248912</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, Fielding B, Asbell PA, Balyeat HD, Cohen EA, Culbertson W, Doughman DJ, Fecko P, McDonald MB, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study 4 years after surgery for myopia. Perk Study Group. JAMA. 1990 Feb 23;263(8):1083-91.</citation>
<PMID>2405203</PMID>
</reference>
<reference>
<citation>Holladay JT, Lynn MJ, Waring GO 3rd, Gemmill M, Keehn GC, Fielding B. The relationship of visual acuity, refractive error, and pupil size after radial keratotomy. Arch Ophthalmol. 1991 Jan;109(1):70-6. doi: 10.1001/archopht.1991.01080010072036.</citation>
<PMID>1987953</PMID>
</reference>
<reference>
<citation>Rowsey JJ, Waring GO 3rd, Monlux RD, Balyeat HD, Stevens SX, Culbertson W, Barron B, Nelson D, Asbell P, Smith R, et al. Corneal topography as a predictor of refractive change in the prospective evaluation of radial keratotomy (PERK) study. Ophthalmic Surg. 1991 Jul;22(7):370-80.</citation>
<PMID>1891181</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, Nizam A, Kutner MH, Cowden JW, Culbertson W, Laibson PR, McDonald MB, Nelson JD, Obstbaum SA, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study five years after surgery. The Perk Study Group. Ophthalmology. 1991 Aug;98(8):1164-76. doi: 10.1016/s0161-6420(91)32156-0.</citation>
<PMID>1923352</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, Strahlman ER, Kutner MH, Culbertson W, Laibson PR, Linstrom RD, McDonald MB, Myers WD, Obstbaum SA, et al. Stability of refraction during four years after radial keratotomy in the prospective evaluation of radial keratotomy study. Am J Ophthalmol. 1991 Feb 15;111(2):133-44. doi: 10.1016/s0002-9394(14)72250-0.</citation>
<PMID>1801760</PMID>
</reference>
<reference>
<citation>Nizam A, Waring GO 3rd, Lynn MJ, Ward MA, Asbell PA, Balyeat HD, Cohen E, Culbertson W, Doughman DJ, Fecko P, et al. Stability of refraction and visual acuity during 5 years in eyes with simple myopia. The PERK Study Group. Refract Corneal Surg. 1992 Nov-Dec;8(6):439-47.</citation>
<PMID>1493117</PMID>
</reference>
<reference>
<citation>Bourque LB, Lynn MJ, Waring GO 3rd, Cartwright C. Spectacle and contact lens wearing six years after radial keratotomy in the Prospective Evaluation of Radial Keratotomy Study. Ophthalmology. 1994 Mar;101(3):421-31. doi: 10.1016/s0161-6420(94)31315-7.</citation>
<PMID>8127562</PMID>
</reference>
<reference>
<citation>Waring GO 3rd, Lynn MJ, McDonnell PJ. Results of the prospective evaluation of radial keratotomy (PERK) study 10 years after surgery. Arch Ophthalmol. 1994 Oct;112(10):1298-308. doi: 10.1001/archopht.1994.01090220048022.</citation>
<PMID>7945032</PMID>
</reference>
<reference>
<citation>McDonnell PJ, Nizam A, Lynn MJ, Waring GO 3rd. Morning-to-evening change in refraction, corneal curvature, and visual acuity 11 years after radial keratotomy in the prospective evaluation of radial keratotomy study. The PERK Study Group. Ophthalmology. 1996 Feb;103(2):233-9. doi: 10.1016/s0161-6420(96)30711-2.</citation>
<PMID>8594507</PMID>
</reference>
<reference>
<citation>Waring GO; Lynn MJ; McDonnell PJ; Resultados del estudio de evaluacion Prospectiva de la Queratotomia Radial (EPQR) 10 anos despues de la cirugia., Arch Ophthalmol (Edicion Espanola) 1995;6:99-110</citation>
</reference>
<reference>
<citation>Nizam A; Waring GO; Lynn MJ; Stability of refraction during 11 years in eyes with simple myopia., Invest Ophthalmol Vis Sci 1996;37:S1004</citation>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myopia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000129
org study id: NEI-28
nct id: NCT00000129
lead sponsor:
To determine whether radial keratotomy is effective in reducing myopia.
To detect complications of the surgery.
To discover patient characteristics and surgical factors affecting the results.
To determine the long-term safety and efficacy of the procedure.
Approximately 11 million Americans have myopia that can be corrected with eyeglasses or
contact lenses. Some of these people may also be candidates for radial keratotomy (RK), a
procedure that aims to correct or reduce myopia by surgery that flattens the corneal
curvature.
Keratotomy was first performed by surgeons in Europe and the United States in the late 1800s,
and the basic optical and mechanical principles of the operation were defined in the 1940s
and 1950s by the Japanese doctors T. Sato and K. Akiyama, who used anterior and posterior
corneal incisions. The posterior incisions damaged the cornea, and the procedure was modified
in the Soviet Union by doctors Fyodorov and V. Durnev to include incisions in only the
anterior cornea. Since its introduction into the United States in 1978, numerous
ophthalmologists have modified the procedure by introducing technical and surgical
improvements such as ultrasonic methods to measure the thickness of the cornea and the use of
diamond-bladed micrometer knives to make the incisions.
However, scientific assessment of RK lagged behind growing public and professional interest
in the procedure. In 1980, in response to widespread concern about the long-term safety and
efficacy of RK, a group of ophthalmic surgeons approached the National Eye Institute with a
proposal for a multicenter clinical trial that would evaluate the potential benefits and
risks of this procedure.
The Prospective Evaluation of Radial Keratotomy study, involving 435 patients and 99 pilot
patients, was a clinical trial designed to evaluate the short- and long-term safety and
efficacy of one technique of radial keratotomy. The procedure was evaluated by comparing a
patient's refractive error and uncorrected vision before and after surgery. The more myopic
eye received surgery first. Patients were required to wait 1 year before having the operation
on the second eye.
The surgical technique was standardized, consisting of eight centrifugal radial incisions
made manually with a diamond micrometer knife. The diameter of the central, uncut, clear zone
was determined by the preoperative spherical equivalent cycloplegic refraction (-2.00 to
-3.12 D = 4.0 mm; -3.25 to -4.3 D = 3.5 mm; -4.50 to -8.00 D = 3.0 mm). The blade length,
which determined the depth of the incision, was set at 100 percent of the thinnest of four
intraoperative ultrasonic corneal thickness readings taken paracentrally at the 3-, 6-, 9-,
and 12-o'clock meridians just outside the mark delineating the clear zone. The incisions were
made from the edge of the trephine mark to the limbal vascular arcade and were spaced
equidistantly around the cornea.
Patients were examined preoperatively and after surgery at 2 weeks, 3 months, 6 months,
annually for 5 years, and at 10 years. Examinations in the morning and evening of the same
day were done at 3 months, 1 year, 3 years, and 11 years in a subset of the patients to test
for diurnal fluctuation of vision and refraction.
The primary outcome variables measured at each visit was the uncorrected and
spectacle-corrected visual acuity and the refractive error with the pupil dilated and
undilated. The corneal shape was measured with central keratometry and photokeratoscopy.
Endothelial function was evaluated using specular microscopy. A slit-lamp microscope
examination was made to check for complications from the incisions. Contrast sensitivity was
tested in a subset of patients. Patient motivation and satisfaction were studied with
psychometric questionnaires at baseline, 1 year, 5-6 years, and 10 years.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Radial Keratotomy
criteria:
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/perkpressrelease.asp
description: NEI Press Release-Ten-Year Results on Radial Keratotomy Released
citation: Waring GO 3rd, Moffitt SD, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, Safir A, Schanzlin DJ, Bourque LB. Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1983 Jan;90(1):40-58. doi: 10.1016/s0161-6420(83)34603-0.
PMID: 6338438
citation: Bourque LB, Rubenstein R, Cosand B, Waring GO 3rd, Moffitt S, Gelender H, Laibson PR, Lindstrom RL, McDonald M, Myers WD, et al. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study. Arch Ophthalmol. 1984 Aug;102(8):1187-92. doi: 10.1001/archopht.1984.01040030965027.
PMID: 6380467
citation: Novak AF; Lindstrom RL; Williams PA; Everson M; Corneal pachymetry prior to radial keratotomy: a comparison of techniques., J Refract Surg 1985;1:151-153
citation: Steinberg EB, Waring GO 3rd. Comparison of two methods of marking the visual axis on the cornea during radial keratotomy. Am J Ophthalmol. 1983 Nov;96(5):605-8. doi: 10.1016/s0002-9394(14)73417-8.
PMID: 6638126
citation: Steinberg EB, Wilson LA, Waring GO 3rd, Lynn MJ, Coles WH. Stellate iron lines in the corneal epithelium after radial keratotomy. Am J Ophthalmol. 1984 Oct 15;98(4):416-21. doi: 10.1016/0002-9394(84)90122-3.
PMID: 6486212
citation: Nelson JD, Williams P, Lindstrom RL, Doughman DJ. Map-fingerprint-dot changes in the corneal epithelial basement membrane following radial keratotomy. Ophthalmology. 1985 Feb;92(2):199-205. doi: 10.1016/s0161-6420(85)34055-1.
PMID: 3872431
citation: Waring GO 3rd, Lynn MJ, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, McDonald MB, Schanzlin DJ, et al. Results of the prospective evaluation of radial keratotomy (PERK) study one year after surgery. Ophthalmology. 1985 Feb;92(2):177-98, 307. doi: 10.1016/s0161-6420(85)34054-x.
PMID: 3885128
citation: Atkin A, Asbell P, Justin N, Smith H, Wayne R, Winterkorn J. Radial keratotomy and glare effects on contrast sensitivity. Doc Ophthalmol. 1986 Feb 28;62(2):129-48. doi: 10.1007/BF00229125.
PMID: 3956364
citation: Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986 Mar;104(3):356-63. doi: 10.1001/archopht.1986.01050150056026.
PMID: 3954634
citation: Bourque LB; Cosand BB; Drews C; Waring GO; Lynn M; Cartwright C; Satisfaccion informada, fluctuacion de la vision y resplandor en pacientes al cabo de un ano tras la cirugia en el estudio de la evaluacion prospectiva de la queratotomia radial (EPQR)., Arch Ophthalmol 1986;2:57-64
citation: Mandelbaum S, Waring GO 3rd, Forster RK, Culbertson WW, Rowsey JJ, Espinal ME. Late development of ulcerative keratitis in radial keratotomy scars. Arch Ophthalmol. 1986 Aug;104(8):1156-60. doi: 10.1001/archopht.1986.01050200062050.
PMID: 3741245
citation: Schanzlin DJ, Santos VR, Waring GO 3rd, Lynn M, Bourque L, Cantillo N, Edwards MA, Justin N, Reinig J, Roszka-Duggan V. Diurnal change in refraction, corneal curvature, visual acuity, and intraocular pressure after radial keratotomy in the PERK Study. Ophthalmology. 1986 Feb;93(2):167-75. doi: 10.1016/s0161-6420(86)33765-5.
PMID: 3951823
citation: Villasenor RA, Santos VR, Cox KC, Harris DF 2nd, Lynn M, Waring GO 3rd. Comparison of ultrasonic corneal thickness measurements before and during surgery in the prospective evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1986 Mar;93(3):327-30. doi: 10.1016/s0161-6420(86)33746-1.
PMID: 3517739
citation: Lynn MJ; Waring GO; Predictability and stability of radial keratotomy., J. Refract Surg 1987;3:193-196
citation: Lynn MJ, Waring GO 3rd, Sperduto RD. Factors affecting outcome and predictability of radial keratotomy in the PERK Study. Arch Ophthalmol. 1987 Jan;105(1):42-51. doi: 10.1001/archopht.1987.01060010048030.
PMID: 3800746
citation: Santos VR, Waring GO 3rd, Lynn MJ, Holladay JT, Sperduto RD. Relationship between refractive error and visual acuity in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1987 Jan;105(1):86-92. doi: 10.1001/archopht.1987.01060010092038.
PMID: 3800751
citation: Waring GO 3rd, Lynn MJ, Culbertson W, Laibson PR, Lindstrom RD, McDonald MB, Myers WD, Obstbaum SA, Rowsey JJ, Schanzlin DJ. Three-year results of the Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1987 Oct;94(10):1339-54. doi: 10.1016/s0161-6420(87)80021-0.
PMID: 3684210
citation: Cartwright CS, Bourque LB, Lynn M, Waring GO 3rd. Relationship of glare to uncorrected visual acuity and cycloplegic refraction 1 year after radial keratotomy in the prospective evaluation of radial keratotomy (PERK) study. J Am Optom Assoc. 1988 Jan;59(1):36-9.
PMID: 3278044
citation: McDonnell PJ, Schanzlin DJ. Early changes in refractive error following radial keratotomy. Arch Ophthalmol. 1988 Feb;106(2):212-4. doi: 10.1001/archopht.1988.01060130222031.
PMID: 3341977
citation: Rowsey JJ, Balyeat HD, Monlux R, Holladay J, Waring GO 3rd, Lynn MJ. Prospective evaluation of radial keratotomy. Photokeratoscope corneal topography. Ophthalmology. 1988 Mar;95(3):322-34. doi: 10.1016/s0161-6420(88)33179-9.
PMID: 3174000
citation: Santos VR, Waring GO 3rd, Lynn MJ, Schanzlin DJ, Cantillo N, Espinal ME, Garbus J, Justin N, Roszka-Duggan V. Morning-to-evening change in refraction, corneal curvature, and visual acuity 2 to 4 years after radial keratotomy in the PERK Study. Ophthalmology. 1988 Nov;95(11):1487-93. doi: 10.1016/s0161-6420(88)32981-7.
PMID: 3211457
citation: Serle JB, Asbell PA, Obstbaum SA, Podos SM, Anh-Le N. The evaluation of corneal endothelial permeability in PERK study patients. Br J Ophthalmol. 1988 Apr;72(4):274-7. doi: 10.1136/bjo.72.4.274.
PMID: 3378023
citation: Lynn MJ, Waring GO 3rd, Nizam A, Kutner MH, Culbertson W, McDonald MB, Meyers WD, Naidoff MA, Nelson JD, Obstbaum SA, et al. Symmetry of refractive and visual acuity outcome in the Prospective Evaluation of Radial Keratotomy (PERK) study. Refract Corneal Surg. 1989 Mar-Apr;5(2):75-81.
PMID: 2488790
citation: Rowsey JJ, Monlux R, Balyeat HD, Stevens SX, Gelender H, Holladay J, Krachmer JH, Laibson P, Lindstrom R, Lynn M, et al. Accuracy and reproducibility of KeraScanner analysis in PERK corneal topography. PERK Study Group. Curr Eye Res. 1989 Jul;8(7):661-74. doi: 10.3109/02713688909025800.
PMID: 2791617
citation: Ginsburg AP, Waring GO 3rd, Steinberg EB, Williams PA, Justin N, Deitz JR, Roszka-Duggan VK, Baluvelt K, Bourque L. Contrast sensitivity under photopic conditions in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Refract Corneal Surg. 1990 Mar-Apr;6(2):82-91.
PMID: 2248920
citation: Lynn MJ, Waring GO 3rd, Carter JT. Combining refractive error and uncorrected visual acuity to assess the effectiveness of refractive corneal surgery. Refract Corneal Surg. 1990 Mar-Apr;6(2):103-9; discussion 109-12.
PMID: 2248912
citation: Waring GO 3rd, Lynn MJ, Fielding B, Asbell PA, Balyeat HD, Cohen EA, Culbertson W, Doughman DJ, Fecko P, McDonald MB, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study 4 years after surgery for myopia. Perk Study Group. JAMA. 1990 Feb 23;263(8):1083-91.
PMID: 2405203
citation: Holladay JT, Lynn MJ, Waring GO 3rd, Gemmill M, Keehn GC, Fielding B. The relationship of visual acuity, refractive error, and pupil size after radial keratotomy. Arch Ophthalmol. 1991 Jan;109(1):70-6. doi: 10.1001/archopht.1991.01080010072036.
PMID: 1987953
citation: Rowsey JJ, Waring GO 3rd, Monlux RD, Balyeat HD, Stevens SX, Culbertson W, Barron B, Nelson D, Asbell P, Smith R, et al. Corneal topography as a predictor of refractive change in the prospective evaluation of radial keratotomy (PERK) study. Ophthalmic Surg. 1991 Jul;22(7):370-80.
PMID: 1891181
citation: Waring GO 3rd, Lynn MJ, Nizam A, Kutner MH, Cowden JW, Culbertson W, Laibson PR, McDonald MB, Nelson JD, Obstbaum SA, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study five years after surgery. The Perk Study Group. Ophthalmology. 1991 Aug;98(8):1164-76. doi: 10.1016/s0161-6420(91)32156-0.
PMID: 1923352
citation: Waring GO 3rd, Lynn MJ, Strahlman ER, Kutner MH, Culbertson W, Laibson PR, Linstrom RD, McDonald MB, Myers WD, Obstbaum SA, et al. Stability of refraction during four years after radial keratotomy in the prospective evaluation of radial keratotomy study. Am J Ophthalmol. 1991 Feb 15;111(2):133-44. doi: 10.1016/s0002-9394(14)72250-0.
PMID: 1801760
citation: Nizam A, Waring GO 3rd, Lynn MJ, Ward MA, Asbell PA, Balyeat HD, Cohen E, Culbertson W, Doughman DJ, Fecko P, et al. Stability of refraction and visual acuity during 5 years in eyes with simple myopia. The PERK Study Group. Refract Corneal Surg. 1992 Nov-Dec;8(6):439-47.
PMID: 1493117
citation: Bourque LB, Lynn MJ, Waring GO 3rd, Cartwright C. Spectacle and contact lens wearing six years after radial keratotomy in the Prospective Evaluation of Radial Keratotomy Study. Ophthalmology. 1994 Mar;101(3):421-31. doi: 10.1016/s0161-6420(94)31315-7.
PMID: 8127562
citation: Waring GO 3rd, Lynn MJ, McDonnell PJ. Results of the prospective evaluation of radial keratotomy (PERK) study 10 years after surgery. Arch Ophthalmol. 1994 Oct;112(10):1298-308. doi: 10.1001/archopht.1994.01090220048022.
PMID: 7945032
citation: McDonnell PJ, Nizam A, Lynn MJ, Waring GO 3rd. Morning-to-evening change in refraction, corneal curvature, and visual acuity 11 years after radial keratotomy in the prospective evaluation of radial keratotomy study. The PERK Study Group. Ophthalmology. 1996 Feb;103(2):233-9. doi: 10.1016/s0161-6420(96)30711-2.
PMID: 8594507
citation: Waring GO; Lynn MJ; McDonnell PJ; Resultados del estudio de evaluacion Prospectiva de la Queratotomia Radial (EPQR) 10 anos despues de la cirugia., Arch Ophthalmol (Edicion Espanola) 1995;6:99-110
citation: Nizam A; Waring GO; Lynn MJ; Stability of refraction during 11 years in eyes with simple myopia., Invest Ophthalmol Vis Sci 1996;37:S1004
mesh term: Myopia
|
NCT0000xxxx/NCT00000130.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000130</url>
</required_header>
<id_info>
<org_study_id>NEI-29</org_study_id>
<nct_id>NCT00000130</nct_id>
</id_info>
<brief_title>Endophthalmitis Vitrectomy Study (EVS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine the role of initial pars plana vitrectomy in the management of postoperative
bacterial endophthalmitis.

To determine the role of intravenous antibiotics in the management of bacterial
endophthalmitis.

To determine which factors, other than treatment, predict outcome in postoperative bacterial
endophthalmitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Endophthalmitis is a serious ocular infection that can result in blindness. Approximately 70
percent of cases occur as a direct complication of intraocular surgery. Current management
requires culture of intraocular contents and administration of an antibiotic. Vitrectomy
surgery, which may help to manage endophthalmitis by removing infecting organisms and their
toxins, has been shown to be of value in various animal models of endophthalmitis. However,
human studies have not shown an advantage to vitrectomy with intraocular antibiotics compared
with intraocular antibiotics alone.

In all large comparison studies to date, eyes with the worst initial presentations were the
ones selected for vitrectomy. Because of the selection bias involved in determining which
cases received vitrectomy, existing clinical information on the efficacy of the procedure for
treating endophthalmitis is inconclusive. Determining the role of initial vitrectomy and the
benefit or lack of benefit to certain subgroups of patients will help the clinician in the
management of endophthalmitis.

In addition, although systemic antibiotics have long been used in the management of
endophthalmitis, there has been little evidence to support their efficacy, but there have
been many reports of toxic systemic effects. In view of this, the role of systemic
antibiotics in the management of endophthalmitis will be assessed.

Endophthalmitis Vitrectomy Study (EVS) patients were randomized to one of two standard
treatment strategies for the management of bacterial endophthalmitis. Eyes received either
(1) initial pars plana vitrectomy with intravitreal antibiotics, followed by retap and
reinjection at 36-60 hours for eyes that did poorly as defined in the study or (2) initial
anterior chamber and vitreous tap/biopsy with injection of intravitreal antibiotics, followed
by vitrectomy and reinjection at 36-60 hours in eyes doing poorly. In addition, all eyes were
randomized to either treatment or no treatment with intravenous antibiotics.

Study end points were visual acuity and clarity of ocular media, the latter assessed both
clinically and photographically. Each patient's initial end point assessment occurred at 3
months, after which procedures to improve vision, such as late vitrectomy for nonclearing
ocular media, were an option. The final outcome assessment occurred at 9 months. Multiple
centers cooperated by enrolling 420 eyes during the 42-month recruitment period.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>February 1990</start_date>
<completion_date type="Actual">January 1995</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Endophthalmitis</condition>
<condition>Eye Infections</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Intravitreal Antibiotics</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Initial Pars Plana Vitrectomy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women were eligible for entry into the EVS if they had clinical signs and symptoms
of bacterial endophthalmitis in an eye that had cataract surgery or lens implantation
within 6 weeks of onset of infection. The involved eye had to have either hypopyon or
enough clouding of anterior chamber or vitreous media to obscure clear visualization of
second-order arterioles, a cornea and anterior chamber in the involved eye clear enough to
visualize some part of the iris, and a cornea clear enough to allow the possibility of pars
plana vitrectomy. The eyes had to have a visual acuity of 20/50 or worse and light
perception or better.

Patients were ineligible when the involved eye was known at the time of study entry to have
had any pre-existing eye disease that limited best-corrected visual acuity to 20/100 or
worse before development of cataract, any intraocular surgery before presentation (except
for cataract extraction or lens implantation), any treatment for endophthalmitis before
presenting at the study center, or any ocular or systemic condition that would prevent
randomization to any of the study groups.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-evs.asp</url>
<description>Clinical Alert to Ophthalmologists</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/evspressrelease.asp</url>
<description>NEI Press Release-New Treatment Options for People With Blinding Eye Infection</description>
</link>
<reference>
<citation>Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. doi: 10.1001/archopht.1997.01100160312008.</citation>
<PMID>9298055</PMID>
</reference>
<reference>
<citation>Doft BH; The Endophthalmitis Vitrectomy Study. Clinical Trials in Ophthalmology. A Summary and Practice Guide, Book Chapter published by Williams & Wilkins 1998:97-111</citation>
</reference>
<reference>
<citation>Johnson MW, Doft BH, Kelsey SF, Barza M, Wilson LA, Barr CC, Wisniewski SR. The Endophthalmitis Vitrectomy Study. Relationship between clinical presentation and microbiologic spectrum. Ophthalmology. 1997 Feb;104(2):261-72. doi: 10.1016/s0161-6420(97)30326-1.</citation>
<PMID>9052630</PMID>
</reference>
<reference>
<citation>Doft BH, Kelsey SF, Wisniewski S, Metz DJ, Lobes L, Rinkoff J, Davis M, Kassoff A. Treatment of endophthalmitis after cataract extraction. Retina. 1994;14(4):297-304. doi: 10.1097/00006982-199414040-00002. Erratum In: Retina 1995;15(1):74.</citation>
<PMID>7817022</PMID>
</reference>
<reference>
<citation>Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.</citation>
<PMID>7487614</PMID>
</reference>
<reference>
<citation>Doft BH, Barza M. Optimal management of postoperative endophthalmitis and results of the Endophthalmitis Vitrectomy Study. Curr Opin Ophthalmol. 1996 Jun;7(3):84-94. doi: 10.1097/00055735-199606000-00015.</citation>
<PMID>10163467</PMID>
</reference>
<reference>
<citation>Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. doi: 10.1016/s0002-9394(14)70380-0.</citation>
<PMID>8956638</PMID>
</reference>
<reference>
<citation>Han DP, Wisniewski SR, Wilson LA, Barza M, Vine AK, Doft BH, Kelsey SF. Spectrum and susceptibilities of microbiologic isolates in the Endophthalmitis Vitrectomy Study. Am J Ophthalmol. 1996 Jul;122(1):1-17. doi: 10.1016/s0002-9394(14)71959-2. Erratum In: Am J Ophthalmol 1996 Dec;122(6):920.</citation>
<PMID>8659579</PMID>
</reference>
<reference>
<citation>Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.</citation>
<PMID>9076208</PMID>
</reference>
<reference>
<citation>Doft BH; Managing infectious endophthalmitis: Results of the EVS., American Academy of Ophthalmology, Focal Points, 1997;XV No. 3</citation>
</reference>
<reference>
<citation>Wisniewski SR, Hammer ME, Grizzard WS, Kelsey SF, Everett D, Packo KH, Yarian DL, Doft BH. An investigation of the hospital charges related to the treatment of endophthalmitis in the Endophthalmitis Vitrectomy Study. Ophthalmology. 1997 May;104(5):739-45. doi: 10.1016/s0161-6420(97)30239-5.</citation>
<PMID>9160017</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Bacterial Endophthalmitis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Endophthalmitis</mesh_term>
<mesh_term>Eye Infections</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Anti-Bacterial Agents</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000130
org study id: NEI-29
nct id: NCT00000130
lead sponsor:
To determine the role of initial pars plana vitrectomy in the management of postoperative
bacterial endophthalmitis.
To determine the role of intravenous antibiotics in the management of bacterial
endophthalmitis.
To determine which factors, other than treatment, predict outcome in postoperative bacterial
endophthalmitis.
Endophthalmitis is a serious ocular infection that can result in blindness. Approximately 70
percent of cases occur as a direct complication of intraocular surgery. Current management
requires culture of intraocular contents and administration of an antibiotic. Vitrectomy
surgery, which may help to manage endophthalmitis by removing infecting organisms and their
toxins, has been shown to be of value in various animal models of endophthalmitis. However,
human studies have not shown an advantage to vitrectomy with intraocular antibiotics compared
with intraocular antibiotics alone.
In all large comparison studies to date, eyes with the worst initial presentations were the
ones selected for vitrectomy. Because of the selection bias involved in determining which
cases received vitrectomy, existing clinical information on the efficacy of the procedure for
treating endophthalmitis is inconclusive. Determining the role of initial vitrectomy and the
benefit or lack of benefit to certain subgroups of patients will help the clinician in the
management of endophthalmitis.
In addition, although systemic antibiotics have long been used in the management of
endophthalmitis, there has been little evidence to support their efficacy, but there have
been many reports of toxic systemic effects. In view of this, the role of systemic
antibiotics in the management of endophthalmitis will be assessed.
Endophthalmitis Vitrectomy Study (EVS) patients were randomized to one of two standard
treatment strategies for the management of bacterial endophthalmitis. Eyes received either
(1) initial pars plana vitrectomy with intravitreal antibiotics, followed by retap and
reinjection at 36-60 hours for eyes that did poorly as defined in the study or (2) initial
anterior chamber and vitreous tap/biopsy with injection of intravitreal antibiotics, followed
by vitrectomy and reinjection at 36-60 hours in eyes doing poorly. In addition, all eyes were
randomized to either treatment or no treatment with intravenous antibiotics.
Study end points were visual acuity and clarity of ocular media, the latter assessed both
clinically and photographically. Each patient's initial end point assessment occurred at 3
months, after which procedures to improve vision, such as late vitrectomy for nonclearing
ocular media, were an option. The final outcome assessment occurred at 9 months. Multiple
centers cooperated by enrolling 420 eyes during the 42-month recruitment period.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Intravitreal Antibiotics
intervention type: Procedure
intervention name: Initial Pars Plana Vitrectomy
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/clinicalalerts/alert-evs.asp
description: Clinical Alert to Ophthalmologists
url: http://www.nei.nih.gov/news/pressreleases/evspressrelease.asp
description: NEI Press Release-New Treatment Options for People With Blinding Eye Infection
citation: Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50. doi: 10.1001/archopht.1997.01100160312008.
PMID: 9298055
citation: Doft BH; The Endophthalmitis Vitrectomy Study. Clinical Trials in Ophthalmology. A Summary and Practice Guide, Book Chapter published by Williams & Wilkins 1998:97-111
citation: Johnson MW, Doft BH, Kelsey SF, Barza M, Wilson LA, Barr CC, Wisniewski SR. The Endophthalmitis Vitrectomy Study. Relationship between clinical presentation and microbiologic spectrum. Ophthalmology. 1997 Feb;104(2):261-72. doi: 10.1016/s0161-6420(97)30326-1.
PMID: 9052630
citation: Doft BH, Kelsey SF, Wisniewski S, Metz DJ, Lobes L, Rinkoff J, Davis M, Kassoff A. Treatment of endophthalmitis after cataract extraction. Retina. 1994;14(4):297-304. doi: 10.1097/00006982-199414040-00002. Erratum In: Retina 1995;15(1):74.
PMID: 7817022
citation: Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.
PMID: 7487614
citation: Doft BH, Barza M. Optimal management of postoperative endophthalmitis and results of the Endophthalmitis Vitrectomy Study. Curr Opin Ophthalmol. 1996 Jun;7(3):84-94. doi: 10.1097/00055735-199606000-00015.
PMID: 10163467
citation: Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. doi: 10.1016/s0002-9394(14)70380-0.
PMID: 8956638
citation: Han DP, Wisniewski SR, Wilson LA, Barza M, Vine AK, Doft BH, Kelsey SF. Spectrum and susceptibilities of microbiologic isolates in the Endophthalmitis Vitrectomy Study. Am J Ophthalmol. 1996 Jul;122(1):1-17. doi: 10.1016/s0002-9394(14)71959-2. Erratum In: Am J Ophthalmol 1996 Dec;122(6):920.
PMID: 8659579
citation: Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
PMID: 9076208
citation: Doft BH; Managing infectious endophthalmitis: Results of the EVS., American Academy of Ophthalmology, Focal Points, 1997;XV No. 3
citation: Wisniewski SR, Hammer ME, Grizzard WS, Kelsey SF, Everett D, Packo KH, Yarian DL, Doft BH. An investigation of the hospital charges related to the treatment of endophthalmitis in the Endophthalmitis Vitrectomy Study. Ophthalmology. 1997 May;104(5):739-45. doi: 10.1016/s0161-6420(97)30239-5.
PMID: 9160017
mesh term: Endophthalmitis
mesh term: Eye Infections
mesh term: Anti-Bacterial Agents
|
NCT0000xxxx/NCT00000131.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000131</url>
</required_header>
<id_info>
<org_study_id>NEI-30</org_study_id>
<nct_id>NCT00000131</nct_id>
</id_info>
<brief_title>Central Vein Occlusion Study (CVOS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether photocoagulation therapy can help prevent iris neovascularization in
eyes with central vein occlusion (CVO) and evidence of ischemic retina.

To assess whether grid-pattern photocoagulation therapy will reduce loss of central visual
acuity due to macular edema secondary to CVO.

To develop new data describing the course and prognosis for eyes with CVO.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Central vein occlusion is a common retinal vascular disorder with potentially blinding
complications. The two major complications are reduced central vision caused by macular edema
and neovascular glaucoma caused by iris neovascularization. Other clinical trials have shown
that laser photocoagulation is an effective treatment for complications found in diabetic
retinopathy and branch vein occlusion, which have some features in common with CVO:
neovascularization and reduced visual acuity caused by macular edema occur in all three
disorders. Evidence from small-scale studies suggests that a grid pattern of photocoagulation
reduces macular edema in CVO patients, although the associated changes in visual acuity are
variable. The CVOS is a detailed investigation of grid pattern photocoagulation in a larger
randomized group of patients.

Eligible patients were divided into four groups:

Group N: Eyes with extensive retinal ischemia (at least 10 disc areas of nonperfusion) were
randomly assigned to receive panretinal photocoagulation or nontreatment unless iris
neovascularization developed.

Group M: Eyes with visual loss ascribable to macular edema were randomly assigned to receive
grid-pattern photocoagulation or nontreatment.

Group P: Eyes with relatively perfused retinas were followed to provide information about the
natural history of the disease.

Group I: Indeterminate eyes in which the retina could not be visualized accurately because of
hemorrhage were followed in a natural history study.

Green argon laser with a slit lamp delivery system was used for all treatments. Photographic
documentation of retinal changes was obtained at entry, post-treatment, and at specified
followup visits for a period of at least 3 years. The frequency of followup visits varied
according to the group to which the CVO patient was assigned. Visual acuity, the primary
outcome factor in the group with macular edema, was measured according to a modified Early
Treatment Diabetic Retinopathy Study protocol at each visit.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>August 1988</start_date>
<completion_date type="Actual">February 1994</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Retinal Vein Occlusion</condition>
<condition>Retinal Diseases</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Photocoagulation Therapy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women must have been age 21 or older and willing to return for followup visits for
3 years following assignment into the appropriate group and randomization. Each of the four
groups has specific eligibility criteria. Patients with retinal vascular disease other than
that specified in the criteria, such as diabetic retinopathy, were ineligible. Patients
with macular disease other than that due to CVO were ineligible for that portion of the
study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Baseline and early natural history report. The Central Vein Occlusion Study. Arch Ophthalmol. 1993 Aug;111(8):1087-95. doi: 10.1001/archopht.1993.01090080083022.</citation>
<PMID>7688950</PMID>
</reference>
<reference>
<citation>Clarkson JG. Central Vein Occlusion Study: photographic protocol and early natural history. Trans Am Ophthalmol Soc. 1994;92:203-13; discussion 213-5. No abstract available.</citation>
<PMID>7533959</PMID>
</reference>
<reference>
<citation>Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4.</citation>
<PMID>9097788</PMID>
</reference>
<reference>
<citation>A randomized clinical trial of early panretinal photocoagulation for ischemic central vein occlusion. The Central Vein Occlusion Study Group N report. Ophthalmology. 1995 Oct;102(10):1434-44.</citation>
<PMID>9097789</PMID>
</reference>
<reference>
<citation>Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006. Erratum In: Arch Ophthalmol 1997 Oct;115(10):1275.</citation>
<PMID>9109757</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Central Vein Occlusion</keyword>
<keyword>Ischemic Retina</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Vein Occlusion</mesh_term>
<mesh_term>Retinal Diseases</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000131
org study id: NEI-30
nct id: NCT00000131
lead sponsor:
To determine whether photocoagulation therapy can help prevent iris neovascularization in
eyes with central vein occlusion (CVO) and evidence of ischemic retina.
To assess whether grid-pattern photocoagulation therapy will reduce loss of central visual
acuity due to macular edema secondary to CVO.
To develop new data describing the course and prognosis for eyes with CVO.
Central vein occlusion is a common retinal vascular disorder with potentially blinding
complications. The two major complications are reduced central vision caused by macular edema
and neovascular glaucoma caused by iris neovascularization. Other clinical trials have shown
that laser photocoagulation is an effective treatment for complications found in diabetic
retinopathy and branch vein occlusion, which have some features in common with CVO:
neovascularization and reduced visual acuity caused by macular edema occur in all three
disorders. Evidence from small-scale studies suggests that a grid pattern of photocoagulation
reduces macular edema in CVO patients, although the associated changes in visual acuity are
variable. The CVOS is a detailed investigation of grid pattern photocoagulation in a larger
randomized group of patients.
Eligible patients were divided into four groups:
Group N: Eyes with extensive retinal ischemia (at least 10 disc areas of nonperfusion) were
randomly assigned to receive panretinal photocoagulation or nontreatment unless iris
neovascularization developed.
Group M: Eyes with visual loss ascribable to macular edema were randomly assigned to receive
grid-pattern photocoagulation or nontreatment.
Group P: Eyes with relatively perfused retinas were followed to provide information about the
natural history of the disease.
Group I: Indeterminate eyes in which the retina could not be visualized accurately because of
hemorrhage were followed in a natural history study.
Green argon laser with a slit lamp delivery system was used for all treatments. Photographic
documentation of retinal changes was obtained at entry, post-treatment, and at specified
followup visits for a period of at least 3 years. The frequency of followup visits varied
according to the group to which the CVO patient was assigned. Visual acuity, the primary
outcome factor in the group with macular edema, was measured according to a modified Early
Treatment Diabetic Retinopathy Study protocol at each visit.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Photocoagulation Therapy
criteria:
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
citation: Baseline and early natural history report. The Central Vein Occlusion Study. Arch Ophthalmol. 1993 Aug;111(8):1087-95. doi: 10.1001/archopht.1993.01090080083022.
PMID: 7688950
citation: Clarkson JG. Central Vein Occlusion Study: photographic protocol and early natural history. Trans Am Ophthalmol Soc. 1994;92:203-13; discussion 213-5. No abstract available.
PMID: 7533959
citation: Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4.
PMID: 9097788
citation: A randomized clinical trial of early panretinal photocoagulation for ischemic central vein occlusion. The Central Vein Occlusion Study Group N report. Ophthalmology. 1995 Oct;102(10):1434-44.
PMID: 9097789
citation: Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006. Erratum In: Arch Ophthalmol 1997 Oct;115(10):1275.
PMID: 9109757
mesh term: Retinal Vein Occlusion
mesh term: Retinal Diseases
|
NCT0000xxxx/NCT00000132.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000132</url>
</required_header>
<id_info>
<org_study_id>NEI-31</org_study_id>
<nct_id>NCT00000132</nct_id>
</id_info>
<brief_title>Early Manifest Glaucoma Trial (EMGT)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
The primary purpose is to compare the effect of immediate therapy to lower the intraocular
pressure (IOP) versus late or no treatment on the progression of newly detected open-angle
glaucoma, as measured by increasing visual field loss and/or optic disc changes.

The secondary purposes are to determine the extent of IOP reduction attained by treatment, to
explore factors that may influence glaucoma progression, and to describe the natural history
of newly detected glaucoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Glaucoma is a common disease in older adults. All present treatment aims at reduction of the
intraocular pressure, but indications for therapy are not well defined. Furthermore, it is
unclear whether intraocular pressure influences the natural history of glaucoma. Against this
background, the primary aim of the study is of central importance to patients with manifest
and suspect glaucoma.

Glaucoma has few subjective symptoms during a long period early in the disease, but damage is
irreversible once it occurs. Early diagnosis and rapid detection of progression are of
paramount importance in limiting this damage, whether through pressure reduction or in some
other way. The effectiveness, if any, of lowering the intraocular pressure in glaucoma
requires evaluation by controlled treatment trials.

The Early Manifest Glaucoma Trial (EMGT) is the first large, controlled, randomized clinical
trial to evaluate the effect of lowering the intraocular pressure on the progression of newly
detected, open-angle glaucoma. This study will compare glaucoma progression in initially
treated versus untreated patients with newly detected open-angle glaucoma and will allow
quantification of the effect of immediate IOP-lowering treatment on progression during the
followup period.

The EMGT is a collaborative effort that involves a Clinical Center at the Department of
Ophthalmology of Malmo University Hospital at the University of Lund, Sweden, and its
Satellite Center in Helsingborg, Sweden; an independent Data Center at the Department of
Preventive Medicine, University Medical Center at Stony Brook, New York; and a Disc
Photography Reading Center at the Department of Ophthalmology in Lund at the University of
Lund. The study was initiated with support from the Swedish Medical Research Council.

Recruitment for the study has been completed. The 255 patients were identified by an
extensive, population-based screening of successive age cohorts as well as by clinical
referral. The diagnosis was confirmed through Humphrey perimetry at two postscreening visits
to the Clinical Center or Satellite Center. Eligible patients who agreed to participate had
two additional visits for collection of baseline data. They were randomized to treatment with
the beta blocker Betaxolol and argon laser trabeculoplasty (treated group) or to no initial
treatment (control group) with close followup of both groups.

Patients are followed for a minimum of 4 years to assess the development of glaucoma
progression. They are seen every 3 months to collect visual field, IOP, and other data. Disc
photographs are taken every 6 months. Technicians and disc photograph graders are masked
regarding treatment assignment. Additional followup visits are held to confirm visual field
progression and IOP elevation (>25 mm Hg in treated group, >35 mm Hg in control group).
Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at more than one
visit; patients in the control group will receive Xalantan whenever IOP reaches 35 mm Hg or
higher during the trial. If IOP remains high, individualized treatment is given. All patients
continue to be followed to monitor the development of end points and will be analyzed in
their originally assigned groups.

The study outcome is glaucoma progression, which is based on specific criteria derived from
analyses of Humphrey visual fields and masked evaluations of disc photographs. The perimetric
outcome is defined as statistically significant deterioration (p < 0.05) of the same three or
more test points in Pattern Deviation Change Probability Maps in three consecutive C30-2
Humphrey fields. Optic disc progression is determined by the following:

- The presence of definite change (detected by comparison of followup photographs with
baseline) by flicker chronoscopy in two followup photographs from the same visit, with
independent confirmation by side-by-side gradings.

- Final confirmation of change toward progression, by flicker chronoscopy and by
side-by-side gradings, at a different followup visit.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>October 1992</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Open-Angle Glaucoma</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Betaxolol</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Laser Trabeculoplasty</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women between ages 50 and 80 years who have newly detected and untreated chronic
open-angle glaucoma with repeatable visual field defects by Humphrey perimetry are eligible
for inclusion.

Exclusion criteria include the following: advanced visual field loss (MD less than or equal
to 16 dB) or threat to fixation; mean IOP > 30 mm Hg or any IOP > 35 mm Hg in at least one
eye; VA < 0.5 in either eye; or any conditions precluding reliable fields or photos, use of
study treatment, or 4-year followup.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
</eligibility>
<location>
<facility>
<name>Department of Ophthalmology, Helsingborg Hospital</name>
<address>
<city>Helsingborg</city>
<country>Sweden</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Malmo University Hospital, University of Lund</name>
<address>
<city>Malmo</city>
<country>Sweden</country>
</address>
</facility>
</location>
<location_countries>
<country>Sweden</country>
</location_countries>
<verification_date>October 2001</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Glaucoma, Open-Angle</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Betaxolol</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000132
org study id: NEI-31
nct id: NCT00000132
lead sponsor:
The primary purpose is to compare the effect of immediate therapy to lower the intraocular
pressure (IOP) versus late or no treatment on the progression of newly detected open-angle
glaucoma, as measured by increasing visual field loss and/or optic disc changes.
The secondary purposes are to determine the extent of IOP reduction attained by treatment, to
explore factors that may influence glaucoma progression, and to describe the natural history
of newly detected glaucoma.
Glaucoma is a common disease in older adults. All present treatment aims at reduction of the
intraocular pressure, but indications for therapy are not well defined. Furthermore, it is
unclear whether intraocular pressure influences the natural history of glaucoma. Against this
background, the primary aim of the study is of central importance to patients with manifest
and suspect glaucoma.
Glaucoma has few subjective symptoms during a long period early in the disease, but damage is
irreversible once it occurs. Early diagnosis and rapid detection of progression are of
paramount importance in limiting this damage, whether through pressure reduction or in some
other way. The effectiveness, if any, of lowering the intraocular pressure in glaucoma
requires evaluation by controlled treatment trials.
The Early Manifest Glaucoma Trial (EMGT) is the first large, controlled, randomized clinical
trial to evaluate the effect of lowering the intraocular pressure on the progression of newly
detected, open-angle glaucoma. This study will compare glaucoma progression in initially
treated versus untreated patients with newly detected open-angle glaucoma and will allow
quantification of the effect of immediate IOP-lowering treatment on progression during the
followup period.
The EMGT is a collaborative effort that involves a Clinical Center at the Department of
Ophthalmology of Malmo University Hospital at the University of Lund, Sweden, and its
Satellite Center in Helsingborg, Sweden; an independent Data Center at the Department of
Preventive Medicine, University Medical Center at Stony Brook, New York; and a Disc
Photography Reading Center at the Department of Ophthalmology in Lund at the University of
Lund. The study was initiated with support from the Swedish Medical Research Council.
Recruitment for the study has been completed. The 255 patients were identified by an
extensive, population-based screening of successive age cohorts as well as by clinical
referral. The diagnosis was confirmed through Humphrey perimetry at two postscreening visits
to the Clinical Center or Satellite Center. Eligible patients who agreed to participate had
two additional visits for collection of baseline data. They were randomized to treatment with
the beta blocker Betaxolol and argon laser trabeculoplasty (treated group) or to no initial
treatment (control group) with close followup of both groups.
Patients are followed for a minimum of 4 years to assess the development of glaucoma
progression. They are seen every 3 months to collect visual field, IOP, and other data. Disc
photographs are taken every 6 months. Technicians and disc photograph graders are masked
regarding treatment assignment. Additional followup visits are held to confirm visual field
progression and IOP elevation (>25 mm Hg in treated group, >35 mm Hg in control group).
Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at more than one
visit; patients in the control group will receive Xalantan whenever IOP reaches 35 mm Hg or
higher during the trial. If IOP remains high, individualized treatment is given. All patients
continue to be followed to monitor the development of end points and will be analyzed in
their originally assigned groups.
The study outcome is glaucoma progression, which is based on specific criteria derived from
analyses of Humphrey visual fields and masked evaluations of disc photographs. The perimetric
outcome is defined as statistically significant deterioration (p < 0.05) of the same three or
more test points in Pattern Deviation Change Probability Maps in three consecutive C30-2
Humphrey fields. Optic disc progression is determined by the following:
- The presence of definite change (detected by comparison of followup photographs with
baseline) by flicker chronoscopy in two followup photographs from the same visit, with
independent confirmation by side-by-side gradings.
- Final confirmation of change toward progression, by flicker chronoscopy and by
side-by-side gradings, at a different followup visit.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Betaxolol
intervention type: Procedure
intervention name: Argon Laser Trabeculoplasty
criteria:
gender: All
minimum age: 50 Years
maximum age: 80 Years
facility:
facility:
country: Sweden
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Betaxolol
|
NCT0000xxxx/NCT00000133.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000133</url>
</required_header>
<id_info>
<org_study_id>NEI-32</org_study_id>
<nct_id>NCT00000133</nct_id>
</id_info>
<brief_title>Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in
certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness
from ROP.

To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and
without cryotherapy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
ROP is a disease of the eyes of prematurely born infants in which the retinal blood vessels
increase in number and branch excessively, sometimes leading to hemorrhage or scarring.
Before the establishment of this study in 1985, more than 500 infants annually were blinded
by ROP in the United States alone.

More than 30 years ago, the National Institutes of Health sponsored a clinical trial that
showed that if premature babies are given oxygen only as needed, the number of infants who
develop ROP drops dramatically. Subsequently, hospitals cut back on giving excessive oxygen
routinely to premature babies. But, with improvements in neonatal care over the last two
decades, the number of babies at risk is increasing as survival rates for smaller premature
infants improve. The lower the birth weight, the higher the incidence and severity of ROP.

In a more recent NEI-supported study at the University of Miami, blood oxygen levels of very
low birth-weight infants were monitored continuously by use of transcutaneous measurements as
long as oxygen therapy was needed. The study showed that there is no statistically
significant difference between the rates of ROP in infants monitored on continuous oxygen
therapy and in those monitored only when they were receiving oxygen in excess of 40 percent.

The Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) trial, also funded by the
NEI, studied whether a slight increase in oxygen therapy would prevent the progression of
moderate ROP to ROP severe enough to require surgical treatment. This intervention made
little or no difference in outcomes.

Likewise, another NEI-sponsored clinical trial (LIGHT-ROP) demonstrated absence of protective
effect on ROP by limiting light exposure to newborn premature infants. These studies have led
to the conclusion that factors other than oxygen or light exposure must be involved in
causing ROP.

In most infants who develop ROP, the disease spontaneously subsides, permitting development
of normal vision. But other infants who progress to a severe form of ROP are in danger of
becoming permanently blind. Although the cause of ROP is not fully explained, scientists are
seeking ways to treat ROP successfully and to find the right time in the progression of the
disease to use treatment. Cryotherapy, which destroys the fringe of the retina through
freezing, is the only treatment so far that has been demonstrated to provide substantial
benefit to these eyes.

The multicenter trial of cryotherapy for ROP enrolled more than 4,000 premature infants who
weighed no more than 1,250 grams at birth. This category of infants is at the greatest risk
of developing ROP. The eyes of the infants enrolled in the study were examined at
predetermined intervals while the subjects were still in the intensive care nursery. After
the pupils were dilated with eye drops, the eyes were examined by an ophthalmologist using a
binocular indirect ophthalmoscope to visualize the developing retina. The natural history of
the condition of each infant's retina was recorded. When examination disclosed the severe
form of ROP (threshold ROP) in both eyes, and the parents gave informed consent, one of the
infant's eyes was randomly selected to receive cryotherapy. In this technique, a cryoprobe
was used to freeze and thus destroy the peripheral extent of the retina, thereby arresting
the development of the blood vessels growing wildly toward it.

Outcome of the therapy was assessed at 3 months and 12 months following randomization by an
extensive examination that included photography of the interior of both the treated and the
control eyes. The 12-month exam also measured visual function with preferential-looking
techniques. Such measurements allowed correlations between fundus photographs and visual
function and a comparison of visual function for treated versus control eyes. Neither the
trained photograph readers who evaluated the pictures from both eyes nor the specially
trained vision testers knew which eyes had received cryotherapy. Additional assessments of
visual acuity and retinal status have been made approximately each year up to the present.
Currently (2001), preparations are being made for a 15-year outcome study that will conclude
by 2003.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1986</start_date>
<completion_date type="Actual">August 2003</completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
</study_design_info>
<condition>Retinopathy of Prematurity</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Trans-scleral Cryotherapy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Premature infants of either gender who were eligible for the natural history study had
weighed less than 1,251 grams at birth and had survived the first 28 days of life. They had
no major ocular or systemic congenital anomalies. Infants who met these criteria and also
had a threshold level of ROP (defined as stage 3+ of the International Classification of
Retinopathy of Prematurity occupying five or more contiguous or eight cumulative 30 degree
sectors [clock hours] of stage 3 ROP in zone I or II in the presence of plus disease) could
be referred for examination to determine eligibility for entry to the cryotherapy trial.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>1 Year</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Alabama Ophthalmology Associates, P.C.</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Private practice of David Plotsky, MD</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retina Group of Washington</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bascom Palmer Eye Institute, University of Miami School of Medicine</name>
<address>
<city>Miami</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Illinois Eye and Ear Infirmary</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Indiana University School of Medicine</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Kentucky Lions Eye Research Institute, University of Louisville</name>
<address>
<city>Louisville</city>
<state>Kentucky</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Tulane University School of Medicine</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wilmer Eye Institute, The Johns Hopkins Medical Institutions</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Private practice of John D. Baker, MD</name>
<address>
<city>Dearborn</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Associated Retinal Consultants, P.C.</name>
<address>
<city>Royal Oak</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Strong Children's Hospital, University of Rochester Medical Center</name>
<address>
<city>Rochester</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University Medical Center</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Private Practice of Miles J. Burke, MD</name>
<address>
<city>Cincinnati</city>
<state>Ohio</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbus Children's Hospital</name>
<address>
<city>Columbus</city>
<state>Ohio</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oregon Health & Science University, Casey Eye Institute</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Children's Hospital of Philadelphia, Division of Pediatric Ophthalmology</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pediatric Ophthalmology and Strabismus, Inc.</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Storm Eye Institute, Medical University of South Carolina</name>
<address>
<city>Charleston</city>
<state>South Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Private practice of Rand Spencer, M.D.</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas Health Science Center, San Antonio, Department of Ophthalmology</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>John Moran Eye Center</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-cryorop.asp</url>
<description>Clinical Alert to Pediatric Ophthalmologists, Retinal Specialists, Neonatologists, and Directors of Neonatal Intensive Care Units</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/roppressrelease.asp</url>
<description>NEI Press Release-Freeze Treatment Reduces Blindness in Premature Infants</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/041496.asp</url>
<description>NIH Press Release-Study Confirms Value Of Treatment To Prevent Blindness In Premature Babies</description>
</link>
<reference>
<citation>Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Pediatrics. 1988 May;81(5):697-706.</citation>
<PMID>2895910</PMID>
</reference>
<reference>
<citation>Multicenter trial of cryotherapy for retinopathy of prematurity. Three-month outcome. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1990 Feb;108(2):195-204. doi: 10.1001/archopht.1990.01070040047029.</citation>
<PMID>2405827</PMID>
</reference>
<reference>
<citation>Dobson V, Quinn GE, Biglan AW, Tung B, Flynn JT, Palmer EA. Acuity card assessment of visual function in the cryotherapy for retinopathy of prematurity trial. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1702-8.</citation>
<PMID>2211019</PMID>
</reference>
<reference>
<citation>Watzke RC, Robertson JE Jr, Palmer EA, Wallace PR, Evans MS, Soldevilla JE. Photographic grading in the retinopathy of prematurity cryotherapy trial. Arch Ophthalmol. 1990 Jul;108(7):950-5. doi: 10.1001/archopht.1990.01070090052038.</citation>
<PMID>2369354</PMID>
</reference>
<reference>
<citation>Hardy RJ, Davis BR, Palmer EA, Tung B. Statistical considerations in terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):293-303. doi: 10.1016/0197-2456(91)90026-i.</citation>
<PMID>1645641</PMID>
</reference>
<reference>
<citation>Palmer EA, Flynn JT, Hardy RJ, Phelps DL, Phillips CL, Schaffer DB, Tung B. Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1991 Nov;98(11):1628-40. doi: 10.1016/s0161-6420(91)32074-8.</citation>
<PMID>1800923</PMID>
</reference>
<reference>
<citation>Palmer EA, Hardy RJ, Davis BR, Stein JA, Mowery RL, Tung B, Phelps DL, Schaffer DB, Flynn JT, Phillips CL. Operational aspects of terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):277-92. doi: 10.1016/0197-2456(91)90025-h.</citation>
<PMID>1645640</PMID>
</reference>
<reference>
<citation>Phelps DL, Brown DR, Tung B, Cassady G, McClead RE, Purohit DM, Palmer EA. 28-day survival rates of 6676 neonates with birth weights of 1250 grams or less. Pediatrics. 1991 Jan;87(1):7-17.</citation>
<PMID>1984621</PMID>
</reference>
<reference>
<citation>Quinn GE, Dobson V, Barr CC, Davis BR, Flynn JT, Palmer EA, Robertson J, Trese MT. Visual acuity in infants after vitrectomy for severe retinopathy of prematurity. Ophthalmology. 1991 Jan;98(1):5-13. doi: 10.1016/s0161-6420(91)32343-1. Erratum In: Ophthalmology. 1991 Jul;98(7):1005.</citation>
<PMID>2023732</PMID>
</reference>
<reference>
<citation>Gilbert WS, Dobson V, Quinn GE, Reynolds J, Tung B, Flynn JT. The correlation of visual function with posterior retinal structure in severe retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 May;110(5):625-31. doi: 10.1001/archopht.1992.01080170047022.</citation>
<PMID>1580837</PMID>
</reference>
<reference>
<citation>Quinn GE, Dobson V, Repka MX, Reynolds J, Kivlin J, Davis B, Buckley E, Flynn JT, Palmer EA. Development of myopia in infants with birth weights less than 1251 grams. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1992 Mar;99(3):329-40. doi: 10.1016/s0161-6420(92)31968-2.</citation>
<PMID>1565444</PMID>
</reference>
<reference>
<citation>Summers G, Phelps DL, Tung B, Palmer EA. Ocular cosmesis in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 Aug;110(8):1092-7. doi: 10.1001/archopht.1992.01080200072027.</citation>
<PMID>1497522</PMID>
</reference>
<reference>
<citation>Trueb L; Evans J; Hammel A; Bartholomew P; Dobson D; Assessing visual acuity of visually impaired children using the Teller acuity cards., Am Orthoptic J 1992;42:149-154</citation>
</reference>
<reference>
<citation>Multicenter trial of cryotherapy for retinopathy of prematurity. 3 1/2-year outcome--structure and function. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Mar;111(3):339-44.</citation>
<PMID>8447743</PMID>
</reference>
<reference>
<citation>Evans MS; Wallace PR; Palmer EA; Fundus photography in small infants., J Ophthal Photography 1993;15(1):38-39</citation>
</reference>
<reference>
<citation>Reynolds J, Dobson V, Quinn GE, Gilbert WS, Tung B, Robertson J, Flynn JT. Prediction of visual function in eyes with mild to moderate posterior pole residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Aug;111(8):1050-6. doi: 10.1001/archopht.1993.01090080046017.</citation>
<PMID>8352687</PMID>
</reference>
<reference>
<citation>Schaffer DB, Palmer EA, Plotsky DF, Metz HS, Flynn JT, Tung B, Hardy RJ. Prognostic factors in the natural course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1993 Feb;100(2):230-7. doi: 10.1016/s0161-6420(93)31665-9.</citation>
<PMID>8437832</PMID>
</reference>
<reference>
<citation>The natural ocular outcome of premature birth and retinopathy. Status at 1 year. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1994 Jul;112(7):903-12. doi: 10.1001/archopht.1994.01090190051021.</citation>
<PMID>8031269</PMID>
</reference>
<reference>
<citation>Dobson V, Quinn GE, Summers CG, Saunders RA, Phelps DL, Tung B, Palmer EA. Effect of acute-phase retinopathy of prematurity on grating acuity development in the very low birth weight infant. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4236-44.</citation>
<PMID>8002243</PMID>
</reference>
<reference>
<citation>Dobson V, Quinn GE, Saunders RA, Spencer R, Davis BR, Risser J, Palmer EA. Grating visual acuity in eyes with retinal residua of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Sep;113(9):1172-7. doi: 10.1001/archopht.1995.01100090098029.</citation>
<PMID>7661752</PMID>
</reference>
<reference>
<citation>Dobson V, Quinn GE, Tung B, Palmer EA, Reynolds JD. Comparison of recognition and grating acuities in very-low-birth-weight children with and without retinal residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1995 Mar;36(3):692-702.</citation>
<PMID>7890499</PMID>
</reference>
<reference>
<citation>Kivlin JD, Biglan AW, Gordon RA, Dobson V, Hardy RA, Palmer EA, Tung B, Gilbert W, Spencer R, Cheng KP, Buckley E. Early retinal vessel development and iris vessel dilatation as factors in retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Cooperative Group. Arch Ophthalmol. 1996 Feb;114(2):150-4. doi: 10.1001/archopht.1996.01100130144005.</citation>
<PMID>8573016</PMID>
</reference>
<reference>
<citation>Quinn GE, Dobson V, Biglan A, Evans J, Plotsky D, Hardy RJ. Correlation of retinopathy of prematurity in fellow eyes in the cryotherapy for retinopathy of prematurity study. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Apr;113(4):469-73. doi: 10.1001/archopht.1995.01100040089032.</citation>
<PMID>7710397</PMID>
</reference>
<reference>
<citation>Bartholomew PA; Chao J; Evans JL; Hammel AM; Trueb AL; Verness JL; Dobson V; Quinn GE; Acceptance/Use of the Teller acuity card procedure in the clinic., Am Orthoptic J 1996;46:100-106</citation>
</reference>
<reference>
<citation>Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity. Snellen visual acuity and structural outcome at 5 1/2 years after randomization. Arch Ophthalmol. 1996 Apr;114(4):417-24. doi: 10.1001/archopht.1996.01100130413008.</citation>
<PMID>8602778</PMID>
</reference>
<reference>
<citation>Dobson V, Quinn GE, Abramov I, Hardy RJ, Tung B, Siatkowski RM, Phelps DL. Color vision measured with pseudoisochromatic plates at five-and-a-half years in eyes of children from the CRYO-ROP study. Invest Ophthalmol Vis Sci. 1996 Nov;37(12):2467-74.</citation>
<PMID>8933763</PMID>
</reference>
<reference>
<citation>Gilbert WS, Quinn GE, Dobson V, Reynolds J, Hardy RJ, Palmer EA. Partial retinal detachment at 3 months after threshold retinopathy of prematurity. Long-term structural and functional outcome. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1996 Sep;114(9):1085-91. doi: 10.1001/archopht.1996.01100140287005.</citation>
<PMID>8790093</PMID>
</reference>
<reference>
<citation>Quinn GE, Dobson V, Barr CC, Davis BR, Palmer EA, Robertson J, Summers CG, Trese MT, Tung B. Visual acuity of eyes after vitrectomy for retinopathy of prematurity: follow-up at 5 1/2 years. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Apr;103(4):595-600. doi: 10.1016/s0161-6420(96)30647-7.</citation>
<PMID>8618758</PMID>
</reference>
<reference>
<citation>Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.</citation>
<PMID>8841302</PMID>
</reference>
<reference>
<citation>Hardy RJ, Palmer EA, Schaffer DB, Phelps DL, Davis BR, Cooper CJ. Outcome-based management of retinopathy of prematurity. Multicenter Trial of Cryotherapy for Retinopathy of prematurity Cooperative Group. J AAPOS. 1997 Mar;1(1):46-54. doi: 10.1016/s1091-8531(97)90023-9. Erratum In: J AAPOS 1997 Sep;1(3):137.</citation>
<PMID>10530985</PMID>
</reference>
<reference>
<citation>Saunders RA, Donahue ML, Christmann LM, Pakalnis AV, Tung B, Hardy RJ, Phelps DL. Racial variation in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1997 May;115(5):604-8. doi: 10.1001/archopht.1997.01100150606005.</citation>
<PMID>9152127</PMID>
</reference>
<reference>
<citation>Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.</citation>
<PMID>2895630</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>February 3, 2014</last_update_submitted>
<last_update_submitted_qc>February 3, 2014</last_update_submitted_qc>
<last_update_posted type="Estimate">February 4, 2014</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Retinopathy of Prematurity</mesh_term>
<mesh_term>Premature Birth</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000133
org study id: NEI-32
nct id: NCT00000133
lead sponsor:
To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in
certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness
from ROP.
To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and
without cryotherapy.
ROP is a disease of the eyes of prematurely born infants in which the retinal blood vessels
increase in number and branch excessively, sometimes leading to hemorrhage or scarring.
Before the establishment of this study in 1985, more than 500 infants annually were blinded
by ROP in the United States alone.
More than 30 years ago, the National Institutes of Health sponsored a clinical trial that
showed that if premature babies are given oxygen only as needed, the number of infants who
develop ROP drops dramatically. Subsequently, hospitals cut back on giving excessive oxygen
routinely to premature babies. But, with improvements in neonatal care over the last two
decades, the number of babies at risk is increasing as survival rates for smaller premature
infants improve. The lower the birth weight, the higher the incidence and severity of ROP.
In a more recent NEI-supported study at the University of Miami, blood oxygen levels of very
low birth-weight infants were monitored continuously by use of transcutaneous measurements as
long as oxygen therapy was needed. The study showed that there is no statistically
significant difference between the rates of ROP in infants monitored on continuous oxygen
therapy and in those monitored only when they were receiving oxygen in excess of 40 percent.
The Supplemental Therapeutic Oxygen for Prethreshold ROP (STOP-ROP) trial, also funded by the
NEI, studied whether a slight increase in oxygen therapy would prevent the progression of
moderate ROP to ROP severe enough to require surgical treatment. This intervention made
little or no difference in outcomes.
Likewise, another NEI-sponsored clinical trial (LIGHT-ROP) demonstrated absence of protective
effect on ROP by limiting light exposure to newborn premature infants. These studies have led
to the conclusion that factors other than oxygen or light exposure must be involved in
causing ROP.
In most infants who develop ROP, the disease spontaneously subsides, permitting development
of normal vision. But other infants who progress to a severe form of ROP are in danger of
becoming permanently blind. Although the cause of ROP is not fully explained, scientists are
seeking ways to treat ROP successfully and to find the right time in the progression of the
disease to use treatment. Cryotherapy, which destroys the fringe of the retina through
freezing, is the only treatment so far that has been demonstrated to provide substantial
benefit to these eyes.
The multicenter trial of cryotherapy for ROP enrolled more than 4,000 premature infants who
weighed no more than 1,250 grams at birth. This category of infants is at the greatest risk
of developing ROP. The eyes of the infants enrolled in the study were examined at
predetermined intervals while the subjects were still in the intensive care nursery. After
the pupils were dilated with eye drops, the eyes were examined by an ophthalmologist using a
binocular indirect ophthalmoscope to visualize the developing retina. The natural history of
the condition of each infant's retina was recorded. When examination disclosed the severe
form of ROP (threshold ROP) in both eyes, and the parents gave informed consent, one of the
infant's eyes was randomly selected to receive cryotherapy. In this technique, a cryoprobe
was used to freeze and thus destroy the peripheral extent of the retina, thereby arresting
the development of the blood vessels growing wildly toward it.
Outcome of the therapy was assessed at 3 months and 12 months following randomization by an
extensive examination that included photography of the interior of both the treated and the
control eyes. The 12-month exam also measured visual function with preferential-looking
techniques. Such measurements allowed correlations between fundus photographs and visual
function and a comparison of visual function for treated versus control eyes. Neither the
trained photograph readers who evaluated the pictures from both eyes nor the specially
trained vision testers knew which eyes had received cryotherapy. Additional assessments of
visual acuity and retinal status have been made approximately each year up to the present.
Currently (2001), preparations are being made for a 15-year outcome study that will conclude
by 2003.
allocation: Randomized
intervention type: Procedure
intervention name: Trans-scleral Cryotherapy
criteria:
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
facility:
facility:
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facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
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facility:
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facility:
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facility:
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country: United States
url: http://www.nei.nih.gov/news/clinicalalerts/alert-cryorop.asp
description: Clinical Alert to Pediatric Ophthalmologists, Retinal Specialists, Neonatologists, and Directors of Neonatal Intensive Care Units
url: http://www.nei.nih.gov/news/pressreleases/roppressrelease.asp
description: NEI Press Release-Freeze Treatment Reduces Blindness in Premature Infants
url: http://www.nei.nih.gov/news/pressreleases/041496.asp
description: NIH Press Release-Study Confirms Value Of Treatment To Prevent Blindness In Premature Babies
citation: Multicenter trial of cryotherapy for retinopathy of prematurity: preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Pediatrics. 1988 May;81(5):697-706.
PMID: 2895910
citation: Multicenter trial of cryotherapy for retinopathy of prematurity. Three-month outcome. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1990 Feb;108(2):195-204. doi: 10.1001/archopht.1990.01070040047029.
PMID: 2405827
citation: Dobson V, Quinn GE, Biglan AW, Tung B, Flynn JT, Palmer EA. Acuity card assessment of visual function in the cryotherapy for retinopathy of prematurity trial. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1702-8.
PMID: 2211019
citation: Watzke RC, Robertson JE Jr, Palmer EA, Wallace PR, Evans MS, Soldevilla JE. Photographic grading in the retinopathy of prematurity cryotherapy trial. Arch Ophthalmol. 1990 Jul;108(7):950-5. doi: 10.1001/archopht.1990.01070090052038.
PMID: 2369354
citation: Hardy RJ, Davis BR, Palmer EA, Tung B. Statistical considerations in terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):293-303. doi: 10.1016/0197-2456(91)90026-i.
PMID: 1645641
citation: Palmer EA, Flynn JT, Hardy RJ, Phelps DL, Phillips CL, Schaffer DB, Tung B. Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1991 Nov;98(11):1628-40. doi: 10.1016/s0161-6420(91)32074-8.
PMID: 1800923
citation: Palmer EA, Hardy RJ, Davis BR, Stein JA, Mowery RL, Tung B, Phelps DL, Schaffer DB, Flynn JT, Phillips CL. Operational aspects of terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Control Clin Trials. 1991 Apr;12(2):277-92. doi: 10.1016/0197-2456(91)90025-h.
PMID: 1645640
citation: Phelps DL, Brown DR, Tung B, Cassady G, McClead RE, Purohit DM, Palmer EA. 28-day survival rates of 6676 neonates with birth weights of 1250 grams or less. Pediatrics. 1991 Jan;87(1):7-17.
PMID: 1984621
citation: Quinn GE, Dobson V, Barr CC, Davis BR, Flynn JT, Palmer EA, Robertson J, Trese MT. Visual acuity in infants after vitrectomy for severe retinopathy of prematurity. Ophthalmology. 1991 Jan;98(1):5-13. doi: 10.1016/s0161-6420(91)32343-1. Erratum In: Ophthalmology. 1991 Jul;98(7):1005.
PMID: 2023732
citation: Gilbert WS, Dobson V, Quinn GE, Reynolds J, Tung B, Flynn JT. The correlation of visual function with posterior retinal structure in severe retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 May;110(5):625-31. doi: 10.1001/archopht.1992.01080170047022.
PMID: 1580837
citation: Quinn GE, Dobson V, Repka MX, Reynolds J, Kivlin J, Davis B, Buckley E, Flynn JT, Palmer EA. Development of myopia in infants with birth weights less than 1251 grams. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1992 Mar;99(3):329-40. doi: 10.1016/s0161-6420(92)31968-2.
PMID: 1565444
citation: Summers G, Phelps DL, Tung B, Palmer EA. Ocular cosmesis in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1992 Aug;110(8):1092-7. doi: 10.1001/archopht.1992.01080200072027.
PMID: 1497522
citation: Trueb L; Evans J; Hammel A; Bartholomew P; Dobson D; Assessing visual acuity of visually impaired children using the Teller acuity cards., Am Orthoptic J 1992;42:149-154
citation: Multicenter trial of cryotherapy for retinopathy of prematurity. 3 1/2-year outcome--structure and function. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Mar;111(3):339-44.
PMID: 8447743
citation: Evans MS; Wallace PR; Palmer EA; Fundus photography in small infants., J Ophthal Photography 1993;15(1):38-39
citation: Reynolds J, Dobson V, Quinn GE, Gilbert WS, Tung B, Robertson J, Flynn JT. Prediction of visual function in eyes with mild to moderate posterior pole residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1993 Aug;111(8):1050-6. doi: 10.1001/archopht.1993.01090080046017.
PMID: 8352687
citation: Schaffer DB, Palmer EA, Plotsky DF, Metz HS, Flynn JT, Tung B, Hardy RJ. Prognostic factors in the natural course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1993 Feb;100(2):230-7. doi: 10.1016/s0161-6420(93)31665-9.
PMID: 8437832
citation: The natural ocular outcome of premature birth and retinopathy. Status at 1 year. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1994 Jul;112(7):903-12. doi: 10.1001/archopht.1994.01090190051021.
PMID: 8031269
citation: Dobson V, Quinn GE, Summers CG, Saunders RA, Phelps DL, Tung B, Palmer EA. Effect of acute-phase retinopathy of prematurity on grating acuity development in the very low birth weight infant. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4236-44.
PMID: 8002243
citation: Dobson V, Quinn GE, Saunders RA, Spencer R, Davis BR, Risser J, Palmer EA. Grating visual acuity in eyes with retinal residua of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Sep;113(9):1172-7. doi: 10.1001/archopht.1995.01100090098029.
PMID: 7661752
citation: Dobson V, Quinn GE, Tung B, Palmer EA, Reynolds JD. Comparison of recognition and grating acuities in very-low-birth-weight children with and without retinal residua of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Invest Ophthalmol Vis Sci. 1995 Mar;36(3):692-702.
PMID: 7890499
citation: Kivlin JD, Biglan AW, Gordon RA, Dobson V, Hardy RA, Palmer EA, Tung B, Gilbert W, Spencer R, Cheng KP, Buckley E. Early retinal vessel development and iris vessel dilatation as factors in retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Cooperative Group. Arch Ophthalmol. 1996 Feb;114(2):150-4. doi: 10.1001/archopht.1996.01100130144005.
PMID: 8573016
citation: Quinn GE, Dobson V, Biglan A, Evans J, Plotsky D, Hardy RJ. Correlation of retinopathy of prematurity in fellow eyes in the cryotherapy for retinopathy of prematurity study. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1995 Apr;113(4):469-73. doi: 10.1001/archopht.1995.01100040089032.
PMID: 7710397
citation: Bartholomew PA; Chao J; Evans JL; Hammel AM; Trueb AL; Verness JL; Dobson V; Quinn GE; Acceptance/Use of the Teller acuity card procedure in the clinic., Am Orthoptic J 1996;46:100-106
citation: Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity. Snellen visual acuity and structural outcome at 5 1/2 years after randomization. Arch Ophthalmol. 1996 Apr;114(4):417-24. doi: 10.1001/archopht.1996.01100130413008.
PMID: 8602778
citation: Dobson V, Quinn GE, Abramov I, Hardy RJ, Tung B, Siatkowski RM, Phelps DL. Color vision measured with pseudoisochromatic plates at five-and-a-half years in eyes of children from the CRYO-ROP study. Invest Ophthalmol Vis Sci. 1996 Nov;37(12):2467-74.
PMID: 8933763
citation: Gilbert WS, Quinn GE, Dobson V, Reynolds J, Hardy RJ, Palmer EA. Partial retinal detachment at 3 months after threshold retinopathy of prematurity. Long-term structural and functional outcome. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1996 Sep;114(9):1085-91. doi: 10.1001/archopht.1996.01100140287005.
PMID: 8790093
citation: Quinn GE, Dobson V, Barr CC, Davis BR, Palmer EA, Robertson J, Summers CG, Trese MT, Tung B. Visual acuity of eyes after vitrectomy for retinopathy of prematurity: follow-up at 5 1/2 years. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Apr;103(4):595-600. doi: 10.1016/s0161-6420(96)30647-7.
PMID: 8618758
citation: Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.
PMID: 8841302
citation: Hardy RJ, Palmer EA, Schaffer DB, Phelps DL, Davis BR, Cooper CJ. Outcome-based management of retinopathy of prematurity. Multicenter Trial of Cryotherapy for Retinopathy of prematurity Cooperative Group. J AAPOS. 1997 Mar;1(1):46-54. doi: 10.1016/s1091-8531(97)90023-9. Erratum In: J AAPOS 1997 Sep;1(3):137.
PMID: 10530985
citation: Saunders RA, Donahue ML, Christmann LM, Pakalnis AV, Tung B, Hardy RJ, Phelps DL. Racial variation in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1997 May;115(5):604-8. doi: 10.1001/archopht.1997.01100150606005.
PMID: 9152127
citation: Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.
PMID: 2895630
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
|
NCT0000xxxx/NCT00000134.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000134</url>
</required_header>
<id_info>
<org_study_id>NEI-33</org_study_id>
<secondary_id>U10EY008057</secondary_id>
<secondary_id>U01AI027668</secondary_id>
<nct_id>NCT00000134</nct_id>
</id_info>
<brief_title>Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)</brief_title>
<acronym>CRRT</acronym>
<official_title>Cytomegalovirus Retinitis Retreatment Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>Johns Hopkins University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Wisconsin, Madison</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Baylor College of Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Tulane University School of Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Icahn School of Medicine at Mount Sinai</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>New York Presbyterian Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>New York University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Northwestern University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Francisco</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Diego</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Miami</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of North Carolina, Chapel Hill</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Memorial Sloan Kettering Cancer Center</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV
retinitis who have been previously treated but whose retinitis either is nonresponsive or has
relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and
(3) combination foscarnet and ganciclovir.

To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis:
(1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. At the time of
this trial, drugs approved by the United States Food and Drug Administration (FDA) for the
treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). Although
most retinitis responds well to initial therapy with systemically administered drugs, given
enough time, nearly all patients will suffer a relapse of the retinitis. Relapsed retinitis
generally responds to reinduction and maintenance therapy, but the interval between
successive relapses progressively shortens. The CRRT addressed the issue of the management of
relapsed CMV retinitis.

The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens in
patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed or
was nonresponsive to initial therapy were randomized to one of three regimens: (1)
intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by
maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg
twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy,
wherein patients continued their previous therapy and were reinduced with the second drug and
then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5
mg/kg/day.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1992</start_date>
<completion_date type="Actual">March 1995</completion_date>
<primary_completion_date type="Actual">March 1995</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Morbidity</measure>
<time_frame>Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial</time_frame>
<description>To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.</description>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">279</enrollment>
<condition>HIV Infections</condition>
<condition>Acquired Immunodeficiency Syndrome</condition>
<condition>Cytomegalovirus Retinitis</condition>
<arm_group>
<arm_group_label>intravenous foscarnet</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</arm_group>
<arm_group>
<arm_group_label>intravenous ganciclovir</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
</arm_group>
<arm_group>
<arm_group_label>combination therapy</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ganciclovir</intervention_name>
<description>intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
<arm_group_label>combination therapy</arm_group_label>
<arm_group_label>intravenous ganciclovir</arm_group_label>
<other_name>cytovene</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Foscarnet</intervention_name>
<description>intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
<arm_group_label>combination therapy</arm_group_label>
<arm_group_label>intravenous foscarnet</arm_group_label>
<other_name>foscavir</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or
older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum
of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an
absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater
than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate
the drug regimens.

exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy
involving the combination of foscarnet and ganciclovir, unwillingness to practice
appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment
not scheduled for surgical repair
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/crrtpressrelease.asp</url>
<description>NEI Press Release-Two Drug Treatment Is Effective Against Recurrent Eye Infection In AIDS Patients</description>
</link>
<reference>
<citation>Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jan;114(1):23-33. doi: 10.1001/archopht.1996.01100130021004.</citation>
<PMID>8540847</PMID>
</reference>
<reference>
<citation>Martin BK, Kaplan Gilpin AM, Jabs DA, Wu AW; Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001 Apr;54(4):376-86. doi: 10.1016/s0895-4356(00)00294-8.</citation>
<PMID>11305288</PMID>
</reference>
<verification_date>August 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>June 15, 2015</results_first_submitted>
<results_first_submitted_qc>August 11, 2015</results_first_submitted_qc>
<results_first_posted type="Estimate">September 14, 2015</results_first_posted>
<last_update_submitted>August 11, 2015</last_update_submitted>
<last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">September 14, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Johns Hopkins Bloomberg School of Public Health</investigator_affiliation>
<investigator_full_name>Curtis Meinert</investigator_full_name>
<investigator_title>Curtis Meinert, PhD</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>HIV Infections</mesh_term>
<mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
<mesh_term>Immunologic Deficiency Syndromes</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ganciclovir</mesh_term>
<mesh_term>Ganciclovir triphosphate</mesh_term>
<mesh_term>Foscarnet</mesh_term>
</intervention_browse>
<clinical_results>
<participant_flow>
<recruitment_details>December 1992</recruitment_details>
<group_list>
<group group_id="P1">
<title>Intravenous Foscarnet</title>
<description>intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
<group group_id="P2">
<title>Intravenous Ganciclovir</title>
<description>intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
</group>
<group group_id="P3">
<title>Combination Therapy</title>
<description>combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="89"/>
<participants group_id="P2" count="94"/>
<participants group_id="P3" count="96"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="89"/>
<participants group_id="P2" count="94"/>
<participants group_id="P3" count="96"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
<participants group_id="P3" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>Intravenous Foscarnet</title>
<description>intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
<group group_id="B2">
<title>Intravenous Ganciclovir</title>
<description>intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
</group>
<group group_id="B3">
<title>Combination Therapy</title>
<description>combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
<group group_id="B4">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="89"/>
<count group_id="B2" value="94"/>
<count group_id="B3" value="96"/>
<count group_id="B4" value="279"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="0"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="89"/>
<measurement group_id="B2" value="94"/>
<measurement group_id="B3" value="96"/>
<measurement group_id="B4" value="279"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="7"/>
<measurement group_id="B2" value="6"/>
<measurement group_id="B3" value="10"/>
<measurement group_id="B4" value="23"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="82"/>
<measurement group_id="B2" value="88"/>
<measurement group_id="B3" value="86"/>
<measurement group_id="B4" value="256"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Region of Enrollment</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>United States</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="89"/>
<measurement group_id="B2" value="94"/>
<measurement group_id="B3" value="96"/>
<measurement group_id="B4" value="279"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Morbidity</title>
<description>To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.</description>
<time_frame>Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial</time_frame>
<group_list>
<group group_id="O1">
<title>Intravenous Foscarnet</title>
<description>intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
<group group_id="O2">
<title>Intravenous Ganciclovir</title>
<description>intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
</group>
<group group_id="O3">
<title>Combination Therapy</title>
<description>combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
</group_list>
<measure>
<title>Morbidity</title>
<description>To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.</description>
<units>participants</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="88"/>
<count group_id="O2" value="93"/>
<count group_id="O3" value="93"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="88"/>
<measurement group_id="O2" value="93"/>
<measurement group_id="O3" value="93"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>1 year, 4 months</time_frame>
<group_list>
<group group_id="E1">
<title>Intravenous Foscarnet</title>
<description>intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
<group group_id="E2">
<title>Intravenous Ganciclovir</title>
<description>intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day</description>
</group>
<group group_id="E3">
<title>Combination Therapy</title>
<description>combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day</description>
</group>
</group_list>
<serious_events>
<default_vocab>serious</default_vocab>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="32" subjects_at_risk="88"/>
<counts group_id="E2" subjects_affected="41" subjects_at_risk="93"/>
<counts group_id="E3" subjects_affected="51" subjects_at_risk="93"/>
</event>
</event_list>
</category>
<category>
<title>Blood and lymphatic system disorders</title>
<event_list>
<event>
<sub_title>Neutropenia</sub_title>
<counts group_id="E1" events="86" subjects_affected="32" subjects_at_risk="88"/>
<counts group_id="E2" events="95" subjects_affected="41" subjects_at_risk="93"/>
<counts group_id="E3" events="107" subjects_affected="51" subjects_at_risk="93"/>
</event>
<event>
<sub_title vocab="other">Thrombocytopenia</sub_title>
<counts group_id="E1" events="28" subjects_affected="14" subjects_at_risk="88"/>
<counts group_id="E2" events="19" subjects_affected="8" subjects_at_risk="93"/>
<counts group_id="E3" events="40" subjects_affected="15" subjects_at_risk="93"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>1</frequency_threshold>
<default_vocab>other</default_vocab>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="7" subjects_at_risk="88"/>
<counts group_id="E2" subjects_affected="7" subjects_at_risk="93"/>
<counts group_id="E3" subjects_affected="10" subjects_at_risk="93"/>
</event>
</event_list>
</category>
<category>
<title>Infections and infestations</title>
<event_list>
<event>
<sub_title>Hospitalizations</sub_title>
<counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="88"/>
<counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="93"/>
<counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="93"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Curtis Meinert, PhD</name_or_title>
<organization>Johns Hopkins University</organization>
<phone>410-955-8198</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000134
org study id: NEI-33
secondary id: U10EY008057
secondary id: U01AI027668
nct id: NCT00000134
lead sponsor:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
has dmc: Yes
To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV
retinitis who have been previously treated but whose retinitis either is nonresponsive or has
relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and
(3) combination foscarnet and ganciclovir.
To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis:
(1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. At the time of
this trial, drugs approved by the United States Food and Drug Administration (FDA) for the
treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). Although
most retinitis responds well to initial therapy with systemically administered drugs, given
enough time, nearly all patients will suffer a relapse of the retinitis. Relapsed retinitis
generally responds to reinduction and maintenance therapy, but the interval between
successive relapses progressively shortens. The CRRT addressed the issue of the management of
relapsed CMV retinitis.
The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens in
patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed or
was nonresponsive to initial therapy were randomized to one of three regimens: (1)
intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by
maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg
twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy,
wherein patients continued their previous therapy and were reinduced with the second drug and
then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5
mg/kg/day.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Morbidity
time frame: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial
description: To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.
arm group label: intravenous foscarnet
arm group type: Experimental
description: intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
arm group label: intravenous ganciclovir
arm group type: Active Comparator
description: intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
arm group label: combination therapy
arm group type: Active Comparator
description: combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
intervention type: Drug
intervention name: Ganciclovir
description: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
arm group label: combination therapy
arm group label: intravenous ganciclovir
other name: cytovene
intervention type: Drug
intervention name: Foscarnet
description: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
arm group label: combination therapy
arm group label: intravenous foscarnet
other name: foscavir
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/crrtpressrelease.asp
description: NEI Press Release-Two Drug Treatment Is Effective Against Recurrent Eye Infection In AIDS Patients
citation: Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jan;114(1):23-33. doi: 10.1001/archopht.1996.01100130021004.
PMID: 8540847
citation: Martin BK, Kaplan Gilpin AM, Jabs DA, Wu AW; Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001 Apr;54(4):376-86. doi: 10.1016/s0895-4356(00)00294-8.
PMID: 11305288
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins Bloomberg School of Public Health
investigator full name: Curtis Meinert
investigator title: Curtis Meinert, PhD
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Immunologic Deficiency Syndromes
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate
mesh term: Foscarnet
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000135.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000135</url>
</required_header>
<id_info>
<org_study_id>NEI-34</org_study_id>
<nct_id>NCT00000135</nct_id>
</id_info>
<brief_title>Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)</brief_title>
<acronym>MACRT</acronym>
<official_title>Monoclonal Antibody CMV Retinitis Trial (MACRT)</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as
adjunct therapy for controlling CMV retinitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. As of September
1996, drugs approved by the United States Food and Drug Administration (FDA) for the
treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir
(Vistide). All systemically administered anti-CMV drugs are given in a similar fashion
consisting of initial 2-week high-dose treatment (induction) to control the infection
followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is
available in both intravenous and oral formulations, foscarnet only in an intravenous
formulation, and cidofovir is given by intermittent intravenous administration. A surgically
implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by
the FDA for the treatment of CMV retinitis.

Despite the use of continuous maintenance therapy, given enough time, all patients with CMV
retinitis on systemically administered drugs relapse. Preliminary studies suggested that the
anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir,
markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial
evaluating MSL-109 as adjunct therapy was conducted.

The MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the
efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis.
Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with
active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was
determined by the treating local physician. The patients enrolled in the trial were
randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2
weeks. Outcomes included survival, retinitis progression, change in amount of retinal area
involved by CMV, loss of visual function (acuity and field), and morbidity.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1995</start_date>
<completion_date type="Actual">August 1996</completion_date>
<primary_completion_date type="Actual">August 1996</primary_completion_date>
<phase>Phase 2/Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Care Provider)</masking>
</study_design_info>
<primary_outcome>
<measure>Mortality Rate</measure>
<time_frame>All patients enrolled were followed for a 17 month period or until a common study closing date</time_frame>
<description>to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .</description>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">209</enrollment>
<condition>HIV Infections</condition>
<condition>Cytomegalovirus Retinitis</condition>
<arm_group>
<arm_group_label>MSL-109</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.</description>
</arm_group>
<arm_group>
<arm_group_label>Placebo</arm_group_label>
<arm_group_type>Placebo Comparator</arm_group_type>
<description>Placebo administered intravenous infusion every 2 weeks 60 mg.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>MSL-109</intervention_name>
<description>60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
<arm_group_label>MSL-109</arm_group_label>
<other_name>Monoclonal antibodies</other_name>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>Placebo</intervention_name>
<description>60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
<arm_group_label>Placebo</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- 13 years or older at entry

- Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC)
definition

- Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at
time of enrollment

- At least one lesion whose size is one-quarter or more optic disc area

- Currently receiving (for relapsed patients) or scheduled to receive (for newly
diagnosed patients) drugs for primary treatment of CMV retinitis that are not
contraindicated for use with MSL-109

- Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more
letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with
poorer visual acuity may be enrolled if the visual acuity impairment is possibly
reversible (eg, due to optic disc edema) and vision is at least light perception in
that eye

- Karnofsky score of 60 or more

- Willingness and ability, with the assistance of a caregiver if necessary, to comply
with treatment and follow up procedures

- signed consent statement

Exclusion criteria:

- Current treatment with intravenous immune globulin (IVIG), CMV immune globulin
(CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2
(IL-2)

- Media opacity that precludes visualization of the fundus in all eyes meeting
eligibility criteria

- Active medical problems, including drug or alcohol abuse, that are considered
sufficient to hinder compliance with treatment or follow up procedures

- Retinal detachment, not scheduled for surgical repair, in all eyes meeting other
eligibility criteria
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<results_reference>
<citation>MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: the Monoclonal Antibody Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group. AIDS Clinical Trials Group. Arch Ophthalmol. 1997 Dec;115(12):1528-36. Erratum In: Arch Ophthalmol 1998 Mar;116(3):296.</citation>
<PMID>9400786</PMID>
</results_reference>
<results_reference>
<citation>Jabs DA, Gilpin AM, Min YI, Erice A, Kempen JH, Quinn TC; Studies of Ocular Complications of AIDS Research Group. HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS. 2002 Apr 12;16(6):877-87. doi: 10.1097/00002030-200204120-00007.</citation>
<PMID>11919489</PMID>
</results_reference>
<results_reference>
<citation>Davidson M, Min YI, Holbrook JT, Van Natta M, Quinn TC, Murphy RL, Welch W, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis. J Infect Dis. 2002 Oct 1;186(7):1013-8. doi: 10.1086/342956. Epub 2002 Aug 29.</citation>
<PMID>12232843</PMID>
</results_reference>
<results_reference>
<citation>Gilpin AM, Holbrook JT, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Control Clin Trials. 2003 Feb;24(1):92-8. doi: 10.1016/s0197-2456(02)00268-4.</citation>
<PMID>12559647</PMID>
</results_reference>
<verification_date>July 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>June 12, 2015</results_first_submitted>
<results_first_submitted_qc>October 14, 2015</results_first_submitted_qc>
<results_first_posted type="Estimate">November 17, 2015</results_first_posted>
<last_update_submitted>October 14, 2015</last_update_submitted>
<last_update_submitted_qc>October 14, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">November 17, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
</condition_browse>
<clinical_results>
<participant_flow>
<recruitment_details>Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician.</recruitment_details>
<pre_assignment_details>Two hundred and nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60mg intravenously every 2 weeks, or placebo,.</pre_assignment_details>
<group_list>
<group group_id="P1">
<title>MSL-109</title>
<description>The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
<group group_id="P2">
<title>Placebo</title>
<description>Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="104"/>
<participants group_id="P2" count="105"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="77"/>
<participants group_id="P2" count="91"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="27"/>
<participants group_id="P2" count="14"/>
</participants_list>
</milestone>
</milestone_list>
<drop_withdraw_reason_list>
<drop_withdraw_reason>
<title>Death</title>
<participants_list>
<participants group_id="P1" count="27"/>
<participants group_id="P2" count="14"/>
</participants_list>
</drop_withdraw_reason>
</drop_withdraw_reason_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>MSL-109</title>
<description>The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
<group group_id="B2">
<title>Placebo</title>
<description>Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
<group group_id="B3">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="104"/>
<count group_id="B2" value="105"/>
<count group_id="B3" value="209"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="104"/>
<measurement group_id="B2" value="105"/>
<measurement group_id="B3" value="209"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="11"/>
<measurement group_id="B2" value="11"/>
<measurement group_id="B3" value="22"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="93"/>
<measurement group_id="B2" value="94"/>
<measurement group_id="B3" value="187"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Region of Enrollment</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>United States</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="104"/>
<measurement group_id="B2" value="105"/>
<measurement group_id="B3" value="209"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Mortality Rate</title>
<description>to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .</description>
<time_frame>All patients enrolled were followed for a 17 month period or until a common study closing date</time_frame>
<group_list>
<group group_id="O1">
<title>MSL-109</title>
<description>The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
<group group_id="O2">
<title>Placebo</title>
<description>Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
</group_list>
<measure>
<title>Mortality Rate</title>
<description>to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .</description>
<units>deaths per person-year</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="104"/>
<count group_id="O2" value="105"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="0.68"/>
<measurement group_id="O2" value="0.31"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>11 months</time_frame>
<group_list>
<group group_id="E1">
<title>MSL-109</title>
<description>The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
<group group_id="E2">
<title>Placebo</title>
<description>Placebo administered intravenous infusion every 2 weeks 60 mg.
MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.</description>
</group>
</group_list>
<serious_events>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="105"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="105"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
</certain_agreements>
<point_of_contact>
<name_or_title>Curtis Meinert, PhD</name_or_title>
<organization>Johns Hopkins University</organization>
<phone>410-955-8198</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000135
org study id: NEI-34
nct id: NCT00000135
lead sponsor:
has dmc: Yes
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as
adjunct therapy for controlling CMV retinitis.
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. As of September
1996, drugs approved by the United States Food and Drug Administration (FDA) for the
treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir
(Vistide). All systemically administered anti-CMV drugs are given in a similar fashion
consisting of initial 2-week high-dose treatment (induction) to control the infection
followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is
available in both intravenous and oral formulations, foscarnet only in an intravenous
formulation, and cidofovir is given by intermittent intravenous administration. A surgically
implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by
the FDA for the treatment of CMV retinitis.
Despite the use of continuous maintenance therapy, given enough time, all patients with CMV
retinitis on systemically administered drugs relapse. Preliminary studies suggested that the
anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir,
markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial
evaluating MSL-109 as adjunct therapy was conducted.
The MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the
efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis.
Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with
active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was
determined by the treating local physician. The patients enrolled in the trial were
randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2
weeks. Outcomes included survival, retinitis progression, change in amount of retinal area
involved by CMV, loss of visual function (acuity and field), and morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Mortality Rate
time frame: All patients enrolled were followed for a 17 month period or until a common study closing date
description: to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .
arm group label: MSL-109
arm group type: Experimental
description: The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered intravenous infusion every 2 weeks 60 mg.
intervention type: Drug
intervention name: MSL-109
description: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
arm group label: MSL-109
other name: Monoclonal antibodies
intervention type: Other
intervention name: Placebo
description: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
arm group label: Placebo
criteria:
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
citation: MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: the Monoclonal Antibody Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group. AIDS Clinical Trials Group. Arch Ophthalmol. 1997 Dec;115(12):1528-36. Erratum In: Arch Ophthalmol 1998 Mar;116(3):296.
PMID: 9400786
citation: Jabs DA, Gilpin AM, Min YI, Erice A, Kempen JH, Quinn TC; Studies of Ocular Complications of AIDS Research Group. HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial. AIDS. 2002 Apr 12;16(6):877-87. doi: 10.1097/00002030-200204120-00007.
PMID: 11919489
citation: Davidson M, Min YI, Holbrook JT, Van Natta M, Quinn TC, Murphy RL, Welch W, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis. J Infect Dis. 2002 Oct 1;186(7):1013-8. doi: 10.1086/342956. Epub 2002 Aug 29.
PMID: 12232843
citation: Gilpin AM, Holbrook JT, Jabs DA, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial. Control Clin Trials. 2003 Feb;24(1):92-8. doi: 10.1016/s0197-2456(02)00268-4.
PMID: 12559647
responsible party type: Sponsor
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000136.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000136</url>
</required_header>
<id_info>
<org_study_id>NEI-35</org_study_id>
<secondary_id>U10EY008057</secondary_id>
<nct_id>NCT00000136</nct_id>
</id_info>
<brief_title>Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)</brief_title>
<acronym>FGCRT</acronym>
<official_title>Foscarnet-Ganciclovir CMV Retinitis Trial</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>Johns Hopkins University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Wisconsin, Madison</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Baylor College of Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Louisiana State University Health Sciences Center in New Orleans</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>New York Presbyterian Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Icahn School of Medicine at Mount Sinai</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>NYU Langone Health</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Northwestern University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Diego</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Francisco</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Miami</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Massachusetts, Worcester</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Memorial Sloan Kettering Cancer Center</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial
treatment of patients with cytomegalovirus (CMV) retinitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. The first two
drugs approved by the United States Food and Drug Administration (FDA) for the treatment of
CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this
trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both
drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy
(induction) to control the infection followed by long-term lower dose therapy to prevent
relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for
CMV retinitis.

The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and
ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV
retinitis were randomized to therapy with either intravenous ganciclovir or intravenous
foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of
visual function (visual acuity and visual field), and morbidity.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>March 1990</start_date>
<completion_date type="Actual">October 1991</completion_date>
<primary_completion_date type="Actual">October 1991</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Mortality</measure>
<time_frame>All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.</time_frame>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">234</enrollment>
<condition>HIV Infections</condition>
<condition>Cytomegalovirus Retinitis</condition>
<arm_group>
<arm_group_label>Foscarnet</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day</description>
</arm_group>
<arm_group>
<arm_group_label>Ganciclovir</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Foscarnet</intervention_name>
<description>60 mg/kg every 8 hours, 90 mg/kg/day</description>
<arm_group_label>Foscarnet</arm_group_label>
<arm_group_label>Ganciclovir</arm_group_label>
<other_name>Foscavir</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ganciclovir</intervention_name>
<description>5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
<arm_group_label>Foscarnet</arm_group_label>
<arm_group_label>Ganciclovir</arm_group_label>
<other_name>Vitraset</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- CMV retinitis in one or both eyes

- At least 1/4 disk are of one CMV lesion photographable

- Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV
infection

- Age 13 and greater

- Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis

- Absolute neutrophil count ≥ 1,000 cells/µl

- Platelet ≥ 25,000 cells/µl

- Serum creatinine ≥ 2.0 mg/dl

- Karnofsky score ≥ 60

- Informed consent

Exclusion criteria:

- Previous treatment of CMV retinitis

- Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the
past 28 days

- Known or suspected allergy to study drugs

- Pregnant or Lactating
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Curtis Meinert, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Johns Hopkins University</affiliation>
</overall_official>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp</url>
<description>http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp</description>
</link>
<reference>
<citation>Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG). Control Clin Trials. 1992 Feb;13(1):22-39. doi: 10.1016/0197-2456(92)90027-w.</citation>
<PMID>1315661</PMID>
</reference>
<reference>
<citation>Assessment of cytomegalovirus retinitis. Clinical evaluation vs centralized grading of fundus photographs. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):791-805.</citation>
<PMID>8660161</PMID>
</reference>
<reference>
<citation>Clinical vs photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):848-55.</citation>
<PMID>8660169</PMID>
</reference>
<reference>
<citation>Wu AW, Coleson LC, Holbrook J, Jabs DA. Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Development of a questionnaire. Studies of Ocular Complication of AIDS Research Group. Arch Ophthalmol. 1996 Jul;114(7):841-7. doi: 10.1001/archopht.1996.01100140055008.</citation>
<PMID>8660168</PMID>
</reference>
<reference>
<citation>Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. Studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trial Group. J Infect Dis. 1997 Jul;176(1):50-8. doi: 10.1086/514039.</citation>
<PMID>9207349</PMID>
</reference>
<reference>
<citation>Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Studies of ocular complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Am J Ophthalmol. 1997 Aug;124(2):141-57.</citation>
<PMID>9262538</PMID>
</reference>
<reference>
<citation>Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS (SOCA) Research Group in Collaboration with the AIDS Clinical Trials Group (ACTG). Am J Ophthalmol. 1997 Jul;124(1):61-70.</citation>
<PMID>9222234</PMID>
</reference>
<reference>
<citation>Studies of Ocular Complications of AIDS Research Group; AIDS Clinical Trials Group. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med. 1992 Jan 23;326(4):213-20. doi: 10.1056/NEJM199201233260401. Erratum In: N Engl J Med 1992 Apr 23;326(17):1172.</citation>
<PMID>1345799</PMID>
</reference>
<reference>
<citation>Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology. 1994 Jul;101(7):1250-61.</citation>
<PMID>8035989</PMID>
</reference>
<reference>
<citation>Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group in collaboration with AIDS Clinical Trials Group. J Infect Dis. 1995 Sep;172(3):613-21. doi: 10.1093/infdis/172.3.613.</citation>
<PMID>7658051</PMID>
</reference>
<reference>
<citation>Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Studies of ocular complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. Arch Intern Med. 1995 Jan 9;155(1):65-74.</citation>
<PMID>7802522</PMID>
</reference>
<reference>
<citation>Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res. 1997 Aug;6(6):481-93. doi: 10.1023/a:1018451930750.</citation>
<PMID>9330549</PMID>
</reference>
<reference>
<citation>Holbrook JT, Davis MD, Hubbard LD, Martin BK, Holland GN, Jabs DA, Gilpin AK, Meinert C, Reshef DS. Risk factors for advancement of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Studies of Ocular Complications of AIDS Research Group. Arch Ophthalmol. 2000 Sep;118(9):1196-204. doi: 10.1001/archopht.118.9.1196.</citation>
<PMID>10980764</PMID>
</reference>
<verification_date>July 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>June 22, 2015</results_first_submitted>
<results_first_submitted_qc>September 22, 2015</results_first_submitted_qc>
<results_first_posted type="Estimate">October 22, 2015</results_first_posted>
<last_update_submitted>September 22, 2015</last_update_submitted>
<last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">October 22, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ganciclovir</mesh_term>
<mesh_term>Ganciclovir triphosphate</mesh_term>
<mesh_term>Foscarnet</mesh_term>
</intervention_browse>
<clinical_results>
<participant_flow>
<group_list>
<group group_id="P1">
<title>Foscarnet</title>
<description>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
<group group_id="P2">
<title>Ganciclovir</title>
<description>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="107"/>
<participants group_id="P2" count="127"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="107"/>
<participants group_id="P2" count="127"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>Foscarnet</title>
<description>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
<group group_id="B2">
<title>Ganciclovir</title>
<description>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
<group group_id="B3">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="107"/>
<count group_id="B2" value="127"/>
<count group_id="B3" value="234"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="107"/>
<measurement group_id="B2" value="127"/>
<measurement group_id="B3" value="234"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="9"/>
<measurement group_id="B2" value="11"/>
<measurement group_id="B3" value="20"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="98"/>
<measurement group_id="B2" value="116"/>
<measurement group_id="B3" value="214"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Region of Enrollment</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>United States</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="107"/>
<measurement group_id="B2" value="127"/>
<measurement group_id="B3" value="234"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Mortality</title>
<time_frame>All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.</time_frame>
<group_list>
<group group_id="O1">
<title>Foscarnet</title>
<description>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
<group group_id="O2">
<title>Ganciclovir</title>
<description>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
</group_list>
<measure>
<title>Mortality</title>
<units>participants</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="107"/>
<count group_id="O2" value="127"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="107"/>
<measurement group_id="O2" value="127"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>1 year, 7 months</time_frame>
<group_list>
<group group_id="E1">
<title>Foscarnet</title>
<description>The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
<group group_id="E2">
<title>Ganciclovir</title>
<description>The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day
Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours</description>
</group>
</group_list>
<serious_events>
<default_assessment>Systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="60" subjects_at_risk="107"/>
<counts group_id="E2" subjects_affected="73" subjects_at_risk="127"/>
</event>
</event_list>
</category>
<category>
<title>Immune system disorders</title>
<event_list>
<event>
<sub_title>Opportunistic Infection</sub_title>
<counts group_id="E1" events="153" subjects_affected="60" subjects_at_risk="107"/>
<counts group_id="E2" events="180" subjects_affected="73" subjects_at_risk="127"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Curtis Meinert, PhD</name_or_title>
<organization>The Johns Hopkins University</organization>
<phone>410-955-8198</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000136
org study id: NEI-35
secondary id: U10EY008057
nct id: NCT00000136
lead sponsor:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
collaborator:
has dmc: Yes
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial
treatment of patients with cytomegalovirus (CMV) retinitis.
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated
to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive
disorder, the end result of which is total retinal destruction and blindness. The first two
drugs approved by the United States Food and Drug Administration (FDA) for the treatment of
CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this
trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both
drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy
(induction) to control the infection followed by long-term lower dose therapy to prevent
relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for
CMV retinitis.
The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and
ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV
retinitis were randomized to therapy with either intravenous ganciclovir or intravenous
foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of
visual function (visual acuity and visual field), and morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mortality
time frame: All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.
arm group label: Foscarnet
arm group type: Experimental
description: The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
arm group label: Ganciclovir
arm group type: Experimental
description: The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
intervention type: Drug
intervention name: Foscarnet
description: 60 mg/kg every 8 hours, 90 mg/kg/day
arm group label: Foscarnet
arm group label: Ganciclovir
other name: Foscavir
intervention type: Drug
intervention name: Ganciclovir
description: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
arm group label: Foscarnet
arm group label: Ganciclovir
other name: Vitraset
criteria:
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Curtis Meinert, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
url: http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp
description: http://www.nei.nih.gov/news/pressreleases/fgcrtpressrelease.asp
citation: Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG). Control Clin Trials. 1992 Feb;13(1):22-39. doi: 10.1016/0197-2456(92)90027-w.
PMID: 1315661
citation: Assessment of cytomegalovirus retinitis. Clinical evaluation vs centralized grading of fundus photographs. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):791-805.
PMID: 8660161
citation: Clinical vs photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):848-55.
PMID: 8660169
citation: Wu AW, Coleson LC, Holbrook J, Jabs DA. Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Development of a questionnaire. Studies of Ocular Complication of AIDS Research Group. Arch Ophthalmol. 1996 Jul;114(7):841-7. doi: 10.1001/archopht.1996.01100140055008.
PMID: 8660168
citation: Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. Studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trial Group. J Infect Dis. 1997 Jul;176(1):50-8. doi: 10.1086/514039.
PMID: 9207349
citation: Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Studies of ocular complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Am J Ophthalmol. 1997 Aug;124(2):141-57.
PMID: 9262538
citation: Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS (SOCA) Research Group in Collaboration with the AIDS Clinical Trials Group (ACTG). Am J Ophthalmol. 1997 Jul;124(1):61-70.
PMID: 9222234
citation: Studies of Ocular Complications of AIDS Research Group; AIDS Clinical Trials Group. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med. 1992 Jan 23;326(4):213-20. doi: 10.1056/NEJM199201233260401. Erratum In: N Engl J Med 1992 Apr 23;326(17):1172.
PMID: 1345799
citation: Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology. 1994 Jul;101(7):1250-61.
PMID: 8035989
citation: Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group in collaboration with AIDS Clinical Trials Group. J Infect Dis. 1995 Sep;172(3):613-21. doi: 10.1093/infdis/172.3.613.
PMID: 7658051
citation: Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Studies of ocular complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. Arch Intern Med. 1995 Jan 9;155(1):65-74.
PMID: 7802522
citation: Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res. 1997 Aug;6(6):481-93. doi: 10.1023/a:1018451930750.
PMID: 9330549
citation: Holbrook JT, Davis MD, Hubbard LD, Martin BK, Holland GN, Jabs DA, Gilpin AK, Meinert C, Reshef DS. Risk factors for advancement of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Studies of Ocular Complications of AIDS Research Group. Arch Ophthalmol. 2000 Sep;118(9):1196-204. doi: 10.1001/archopht.118.9.1196.
PMID: 10980764
responsible party type: Sponsor
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate
mesh term: Foscarnet
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000137.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000137</url>
</required_header>
<id_info>
<org_study_id>NEI-36</org_study_id>
<nct_id>NCT00000137</nct_id>
</id_info>
<brief_title>Collaborative Corneal Transplantation Studies (CCTS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether histocompatibility matching of corneal transplant donors and recipients
can reduce the incidence of graft rejection in high-risk patients.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Approximately 20 percent of corneal transplant patients, about 6,000 per year, face donor
tissue rejection at rates of up to 60 percent because of corneal vascularization or prior
graft rejection. Histocompatibility antigen matching and/or crossmatching may have offered
these patients an improved chance for successful outcome.

The Collaborative Corneal Transplantation Studies Group conducted two controlled,
double-masked studies addressing distinct scientific questions about donor-recipient
histocompatibility matching. The Crossmatch Study was a randomized study assessing the
effectiveness of crossmatching in preventing graft rejection among high-risk patients with
lymphocytotoxic antibodies. The Antigen Matching Study was a prospective, double-masked,
observational study of the effectiveness of HLA-A, -B, and -DR donor-recipient matching in
high-risk patients who had no lymphocytotoxic antibodies.

Six clinical centers recruited high-risk patients and collaborated with their local eye
banking and organ procurement agencies in procuring donor corneal tissue. For each of the two
studies, a total of 400 patients were sought. Blood samples from each enrolled patient were
sent to the local CCTS tissue typing laboratory for HLA typing, and serum samples were sent
to the Central Laboratory to be screened for preformed lymphocytotoxic antibodies. Depending
on the results of the testing, patients were entered into the Crossmatch Study or the Antigen
Matching Study.

As corneal donors became available, donor blood samples were HLA typed at the local
laboratories and crossmatched against all CCTS patients who awaited transplantation. Results
of the testing were entered in a national, 24-hour computerized allocation system operated by
the United Network for Organ Sharing (UNOS). Patients in the Crossmatch Study received a
cornea from either a positively crossmatched donor or a negatively crossmatched donor.
Patients in the Antigen Matching Study received a cornea with 0 to 6 matched antigens.

Transplant patients were followed intensively during the first months after surgery. The
number of clinic visits was tapered to 2 during the third and final year of followup,
resulting in a total of 17 postoperative visits. Irreversible failure of the corneal
allograft due to all causes was the primary outcome variable in both studies. Allograft
reaction episodes, irreversible failure due to rejection, and visual acuity were secondary
outcome variables.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1986</start_date>
<completion_date type="Actual">September 1989</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Corneal Transplantation</condition>
<condition>Graft Rejection</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Histocompatibility Matching</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Males and females age 10 years or older with two to four quadrants of corneal stroma
vascularization or a history of allograft rejection in the eye considered for surgery were
eligible for both studies in the CCTS.

Patients must have been willing to participate in 3 years of followup. No one was eligible
for the CCTS who had a condition that would greatly increase the risk of nonrejection graft
failure, such as xerophthalmia or severe exposure keratopathy. Also excluded were patients
with systemic diseases or with medication usage that might alter their immune response.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>10 Years</minimum_age>
<maximum_age>N/A</maximum_age>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/101492.asp</url>
<description>NEI Press Release-Patient/Donor Blood Type Matching Improves Corneal Transplantation Outcome</description>
</link>
<reference>
<citation>Stark WJ, Stulting RD, Thoft R. HLA matching and corneal transplantation. N Engl J Med. 1987 Dec 3;317(23):1476-7. doi: 10.1056/NEJM198712033172311. No abstract available.</citation>
<PMID>3317044</PMID>
</reference>
<reference>
<citation>Klein PK; Stark WJ; Maguire MG; Stulting RD; Collaborative Corneal Transplantation Research Group; Donor-recipient crossmatching and typing to avoid corneal allograft rejection, in Cavanaugh HD (ed)., The Cornea: The World Congress on the Cornea III, New York, Raven Press, 1988:395-398</citation>
</reference>
<reference>
<citation>Stark WJ, Stulting RD, Meyer RF, Foulks GN, Smith RE, Chandler JW, Maguire MG, Bias WB. Sharing tissue typing information from the collaborative corneal transplantation studies. Arch Ophthalmol. 1989 May;107(5):633. doi: 10.1001/archopht.1989.01070010651004. No abstract available.</citation>
<PMID>2655566</PMID>
</reference>
<reference>
<citation>The collaborative corneal transplantation studies (CCTS). Effectiveness of histocompatibility matching in high-risk corneal transplantation. The Collaborative Corneal Transplantation Studies Research Group. Arch Ophthalmol. 1992 Oct;110(10):1392-403.</citation>
<PMID>1417537</PMID>
</reference>
<reference>
<citation>McDonnell PJ, Enger C, Stark WJ, Stulting RD. Corneal thickness changes after high-risk penetrating keratoplasty. Collaborative Corneal Transplantation Study Group. Arch Ophthalmol. 1993 Oct;111(10):1374-81. doi: 10.1001/archopht.1993.01090100082032.</citation>
<PMID>8216018</PMID>
</reference>
<reference>
<citation>Fink N, Stark WJ, Maguire MG, Stulting D, Meyer R, Foulks G, Smith RE, Rapoza P. Effectiveness of histocompatibility matching in high-risk corneal transplantation: a summary of results from the Collaborative Corneal Transplantation Studies. Cesk Oftalmol. 1994 Feb;50(1):3-12.</citation>
<PMID>8137435</PMID>
</reference>
<reference>
<citation>Maguire MG, Stark WJ, Gottsch JD, Stulting RD, Sugar A, Fink NE, Schwartz A. Risk factors for corneal graft failure and rejection in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Ophthalmology. 1994 Sep;101(9):1536-47. doi: 10.1016/s0161-6420(94)31138-9.</citation>
<PMID>8090456</PMID>
</reference>
<reference>
<citation>Hahn AB, Foulks GN, Enger C, Fink N, Stark WJ, Hopkins KA, Sanfilippo F. The association of lymphocytotoxic antibodies with corneal allograft rejection in high risk patients. The Collaborative Corneal Transplantation Studies Research Group. Transplantation. 1995 Jan 15;59(1):21-7. doi: 10.1097/00007890-199501150-00005.</citation>
<PMID>7839424</PMID>
</reference>
<reference>
<citation>Kamp MT, Fink NE, Enger C, Maguire MG, Stark WJ, Stulting RD. Patient-reported symptoms associated with graft reactions in high-risk patients in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Cornea. 1995 Jan;14(1):43-8.</citation>
<PMID>7712736</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000137
org study id: NEI-36
nct id: NCT00000137
lead sponsor:
To determine whether histocompatibility matching of corneal transplant donors and recipients
can reduce the incidence of graft rejection in high-risk patients.
Approximately 20 percent of corneal transplant patients, about 6,000 per year, face donor
tissue rejection at rates of up to 60 percent because of corneal vascularization or prior
graft rejection. Histocompatibility antigen matching and/or crossmatching may have offered
these patients an improved chance for successful outcome.
The Collaborative Corneal Transplantation Studies Group conducted two controlled,
double-masked studies addressing distinct scientific questions about donor-recipient
histocompatibility matching. The Crossmatch Study was a randomized study assessing the
effectiveness of crossmatching in preventing graft rejection among high-risk patients with
lymphocytotoxic antibodies. The Antigen Matching Study was a prospective, double-masked,
observational study of the effectiveness of HLA-A, -B, and -DR donor-recipient matching in
high-risk patients who had no lymphocytotoxic antibodies.
Six clinical centers recruited high-risk patients and collaborated with their local eye
banking and organ procurement agencies in procuring donor corneal tissue. For each of the two
studies, a total of 400 patients were sought. Blood samples from each enrolled patient were
sent to the local CCTS tissue typing laboratory for HLA typing, and serum samples were sent
to the Central Laboratory to be screened for preformed lymphocytotoxic antibodies. Depending
on the results of the testing, patients were entered into the Crossmatch Study or the Antigen
Matching Study.
As corneal donors became available, donor blood samples were HLA typed at the local
laboratories and crossmatched against all CCTS patients who awaited transplantation. Results
of the testing were entered in a national, 24-hour computerized allocation system operated by
the United Network for Organ Sharing (UNOS). Patients in the Crossmatch Study received a
cornea from either a positively crossmatched donor or a negatively crossmatched donor.
Patients in the Antigen Matching Study received a cornea with 0 to 6 matched antigens.
Transplant patients were followed intensively during the first months after surgery. The
number of clinic visits was tapered to 2 during the third and final year of followup,
resulting in a total of 17 postoperative visits. Irreversible failure of the corneal
allograft due to all causes was the primary outcome variable in both studies. Allograft
reaction episodes, irreversible failure due to rejection, and visual acuity were secondary
outcome variables.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Procedure
intervention name: Histocompatibility Matching
criteria:
gender: All
minimum age: 10 Years
maximum age: N/A
url: http://www.nei.nih.gov/news/pressreleases/101492.asp
description: NEI Press Release-Patient/Donor Blood Type Matching Improves Corneal Transplantation Outcome
citation: Stark WJ, Stulting RD, Thoft R. HLA matching and corneal transplantation. N Engl J Med. 1987 Dec 3;317(23):1476-7. doi: 10.1056/NEJM198712033172311. No abstract available.
PMID: 3317044
citation: Klein PK; Stark WJ; Maguire MG; Stulting RD; Collaborative Corneal Transplantation Research Group; Donor-recipient crossmatching and typing to avoid corneal allograft rejection, in Cavanaugh HD (ed)., The Cornea: The World Congress on the Cornea III, New York, Raven Press, 1988:395-398
citation: Stark WJ, Stulting RD, Meyer RF, Foulks GN, Smith RE, Chandler JW, Maguire MG, Bias WB. Sharing tissue typing information from the collaborative corneal transplantation studies. Arch Ophthalmol. 1989 May;107(5):633. doi: 10.1001/archopht.1989.01070010651004. No abstract available.
PMID: 2655566
citation: The collaborative corneal transplantation studies (CCTS). Effectiveness of histocompatibility matching in high-risk corneal transplantation. The Collaborative Corneal Transplantation Studies Research Group. Arch Ophthalmol. 1992 Oct;110(10):1392-403.
PMID: 1417537
citation: McDonnell PJ, Enger C, Stark WJ, Stulting RD. Corneal thickness changes after high-risk penetrating keratoplasty. Collaborative Corneal Transplantation Study Group. Arch Ophthalmol. 1993 Oct;111(10):1374-81. doi: 10.1001/archopht.1993.01090100082032.
PMID: 8216018
citation: Fink N, Stark WJ, Maguire MG, Stulting D, Meyer R, Foulks G, Smith RE, Rapoza P. Effectiveness of histocompatibility matching in high-risk corneal transplantation: a summary of results from the Collaborative Corneal Transplantation Studies. Cesk Oftalmol. 1994 Feb;50(1):3-12.
PMID: 8137435
citation: Maguire MG, Stark WJ, Gottsch JD, Stulting RD, Sugar A, Fink NE, Schwartz A. Risk factors for corneal graft failure and rejection in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Ophthalmology. 1994 Sep;101(9):1536-47. doi: 10.1016/s0161-6420(94)31138-9.
PMID: 8090456
citation: Hahn AB, Foulks GN, Enger C, Fink N, Stark WJ, Hopkins KA, Sanfilippo F. The association of lymphocytotoxic antibodies with corneal allograft rejection in high risk patients. The Collaborative Corneal Transplantation Studies Research Group. Transplantation. 1995 Jan 15;59(1):21-7. doi: 10.1097/00007890-199501150-00005.
PMID: 7839424
citation: Kamp MT, Fink NE, Enger C, Maguire MG, Stark WJ, Stulting RD. Patient-reported symptoms associated with graft reactions in high-risk patients in the collaborative corneal transplantation studies. Collaborative Corneal Transplantation Studies Research Group. Cornea. 1995 Jan;14(1):43-8.
PMID: 7712736
|
NCT0000xxxx/NCT00000138.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000138</url>
</required_header>
<id_info>
<org_study_id>NEI-37</org_study_id>
<nct_id>NCT00000138</nct_id>
</id_info>
<brief_title>Herpetic Eye Disease Study (HEDS) I</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal
keratitis in conjunction with topical trifluridine.

To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in
patients receiving concomitant topical corticosteroids and trifluridine.

To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in
conjunction with treatment with topical corticosteroids and trifluridine.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Herpes simplex keratitis is a leading cause of corneal opacification in the United States,
other industrialized countries, and developing nations throughout the world. An estimated
450,000 people in the United States can develop recurrent episodes of the disease and about
46,000 episodes of HSV eye infection every year. Herpetic eye disease is the most common
infectious cause of corneal blindness in this country.

Despite the availability of antiviral agents that are effective in treating herpes simplex
epithelial keratitis, inflammation in the corneal connective tissue and iris that can lead to
corneal scarring and visual impairment develops in many patients. Prior to the HEDS-I trials,
the role of topical corticosteroids in the management of HSV stromal keratitis was uncertain;
some animal and human studies suggested there was a benefit to treatment whereas others
suggested harm. The value of adding an oral antiviral agent to treatment with topical
corticosteroids and topical antivirals also was unknown.

The HEDS-I trials were developed to assess the efficacy of topical corticosteroids and oral
acyclovir in treating HSV stromal keratitis and iridocyclitis.

HEDS-I consisted of three randomized, placebo-controlled trials. The organizational structure
consisted of a data coordinating center and eight clinical centers.

All patients received the topical antiviral trifluridine as prophylaxis against recurrences
of HSV epithelial ulceration. Patients were evaluated weekly for 10 weeks, every other week
through week 16, and again at 6 months. The primary outcome was the time to development of
preset criteria for treatment failure during the 16-week period of examination.
Protocol-specific descriptions of the three trials follow.

Herpes Stromal Keratitis, Not on Steroid Trial (HEDS-SKN): Patients with active HSV stromal
keratitis who had not used a topical corticosteroid in the preceding 10 days were randomized
to treatment with topical prednisolone phosphate drops or topical placebo drops. A treatment
schedule, starting with 8 drops a day of 1 percent prednisolone phosphate for 7 days, was
progressively decreased over 10 weeks in such a way that patients received 1 drop per day of
1/8 percent prednisolone for the last 3 weeks of treatment. Placebo drops were given by the
same schedule.

Herpes Stromal Keratitis, on Steroid Treatment (HEDS-SKS): Patients with active HSV stromal
keratitis who already were being treated with a topical corticosteroid were randomized either
to oral treatment with 200 mg acyclovir capsules (400 mg five times daily) for 10 weeks or to
the identical dose of placebo capsules. Patients also received topical prednisolone phosphate
in the dosage schedule described above for the SKN trial.

Herpes Simplex Virus Iridocyclitis, Receiving Topical Steroids (HEDS-IRT): Patients with
active HSV iridocyclitis were randomized either to oral treatment with 200 mg acyclovir
capsules (400 mg five times daily) for 10 weeks or to the identical dose of placebo capsules.
Patients also received topical prednisolone phosphate in the dosage schedule described above
for the SKN trial.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>May 1989</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Keratitis, Herpetic</condition>
<condition>Ocular Herpes Simplex</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Prednisolone Phosphate</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Acyclovir</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Eligibility criteria common to the three protocols included age 12 years or older, no
active HSV epithelial keratitis, no prior keratoplasty of the involved eye, and not
pregnant. Protocol-specific criteria are noted in the description above.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>12 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Dawson CR. The herpetic Eye Disease Study. Arch Ophthalmol. 1990 Feb;108(2):191-2. doi: 10.1001/archopht.1990.01070040043027. No abstract available.</citation>
<PMID>2405826</PMID>
</reference>
<reference>
<citation>Dawson CR; Jones DB; Kaufman HE; Barron BA; Hauck WW; Wilhelmus KR; The Herpetic Eye Disease Study: Strategies of design and data analysis [Abstract]., Invest Ophthalmol Vis Sci 1990;31:553</citation>
</reference>
<reference>
<citation>Dawson CR, Jones DB, Kaufman HE, Barron BA, Hauck WW, Wilhelmus KR. Design and organization of the herpetic eye disease study (HEDS). Curr Eye Res. 1991;10 Suppl:105-10. doi: 10.3109/02713689109020365.</citation>
<PMID>1864086</PMID>
</reference>
<reference>
<citation>Dawson CR; Jones DB; Wilhelmus KR; Kaufman HE; Barron BA; Hauck WW; Evaluation of corneal inflammatory disease: The Herpetic Eye Disease Study (HEDS) [Abstract]., Invest Ophthalmol Vis Sci 1991;32:1221</citation>
</reference>
<reference>
<citation>Dawson CR; Hauck WW; Jones DB; Kaufman HE; Gee L; Barron BA; Wilhelmus KR; The Herpetic Eye Disease Study (HEDS). Clinical characteristics of randomized patients with herpetic stromal keratitis and iridocyclitis prior to initiating treatment [Abstract]., Invest Ophthalmol Vis 1992;33:1134</citation>
</reference>
<reference>
<citation>Barron BA, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Wilhelmus KR, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of oral acyclovir for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1871-82. doi: 10.1016/s0161-6420(13)31155-5.</citation>
<PMID>7997323</PMID>
</reference>
<reference>
<citation>Wilhelmus KR, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Barron BA, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of topical corticosteroids for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1883-95; discussion 1895-6. doi: 10.1016/s0161-6420(94)31087-6.</citation>
<PMID>7997324</PMID>
</reference>
<reference>
<citation>A controlled trial of oral acyclovir for iridocyclitis caused by herpes simplex virus. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1996 Sep;114(9):1065-72. doi: 10.1001/archopht.1996.01100140267002.</citation>
<PMID>8790090</PMID>
</reference>
<reference>
<citation>Wilhelmus KR, Dawson CR, Barron BA, Bacchetti P, Gee L, Jones DB, Kaufman HE, Sugar J, Hyndiuk RA, Laibson PR, Stulting RD, Asbell PA. Risk factors for herpes simplex virus epithelial keratitis recurring during treatment of stromal keratitis or iridocyclitis. Herpetic Eye Disease Study Group. Br J Ophthalmol. 1996 Nov;80(11):969-72. doi: 10.1136/bjo.80.11.969.</citation>
<PMID>8976723</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Herpes Simplex Stromal Keratitis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Herpes Simplex</mesh_term>
<mesh_term>Keratitis, Herpetic</mesh_term>
<mesh_term>Keratitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acyclovir</mesh_term>
<mesh_term>Prednisolone</mesh_term>
<mesh_term>Methylprednisolone Acetate</mesh_term>
<mesh_term>Methylprednisolone</mesh_term>
<mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
<mesh_term>Prednisolone acetate</mesh_term>
<mesh_term>Prednisolone hemisuccinate</mesh_term>
<mesh_term>Prednisolone phosphate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000138
org study id: NEI-37
nct id: NCT00000138
lead sponsor:
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal
keratitis in conjunction with topical trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in
patients receiving concomitant topical corticosteroids and trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in
conjunction with treatment with topical corticosteroids and trifluridine.
Herpes simplex keratitis is a leading cause of corneal opacification in the United States,
other industrialized countries, and developing nations throughout the world. An estimated
450,000 people in the United States can develop recurrent episodes of the disease and about
46,000 episodes of HSV eye infection every year. Herpetic eye disease is the most common
infectious cause of corneal blindness in this country.
Despite the availability of antiviral agents that are effective in treating herpes simplex
epithelial keratitis, inflammation in the corneal connective tissue and iris that can lead to
corneal scarring and visual impairment develops in many patients. Prior to the HEDS-I trials,
the role of topical corticosteroids in the management of HSV stromal keratitis was uncertain;
some animal and human studies suggested there was a benefit to treatment whereas others
suggested harm. The value of adding an oral antiviral agent to treatment with topical
corticosteroids and topical antivirals also was unknown.
The HEDS-I trials were developed to assess the efficacy of topical corticosteroids and oral
acyclovir in treating HSV stromal keratitis and iridocyclitis.
HEDS-I consisted of three randomized, placebo-controlled trials. The organizational structure
consisted of a data coordinating center and eight clinical centers.
All patients received the topical antiviral trifluridine as prophylaxis against recurrences
of HSV epithelial ulceration. Patients were evaluated weekly for 10 weeks, every other week
through week 16, and again at 6 months. The primary outcome was the time to development of
preset criteria for treatment failure during the 16-week period of examination.
Protocol-specific descriptions of the three trials follow.
Herpes Stromal Keratitis, Not on Steroid Trial (HEDS-SKN): Patients with active HSV stromal
keratitis who had not used a topical corticosteroid in the preceding 10 days were randomized
to treatment with topical prednisolone phosphate drops or topical placebo drops. A treatment
schedule, starting with 8 drops a day of 1 percent prednisolone phosphate for 7 days, was
progressively decreased over 10 weeks in such a way that patients received 1 drop per day of
1/8 percent prednisolone for the last 3 weeks of treatment. Placebo drops were given by the
same schedule.
Herpes Stromal Keratitis, on Steroid Treatment (HEDS-SKS): Patients with active HSV stromal
keratitis who already were being treated with a topical corticosteroid were randomized either
to oral treatment with 200 mg acyclovir capsules (400 mg five times daily) for 10 weeks or to
the identical dose of placebo capsules. Patients also received topical prednisolone phosphate
in the dosage schedule described above for the SKN trial.
Herpes Simplex Virus Iridocyclitis, Receiving Topical Steroids (HEDS-IRT): Patients with
active HSV iridocyclitis were randomized either to oral treatment with 200 mg acyclovir
capsules (400 mg five times daily) for 10 weeks or to the identical dose of placebo capsules.
Patients also received topical prednisolone phosphate in the dosage schedule described above
for the SKN trial.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Prednisolone Phosphate
intervention type: Drug
intervention name: Acyclovir
criteria:
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
citation: Dawson CR. The herpetic Eye Disease Study. Arch Ophthalmol. 1990 Feb;108(2):191-2. doi: 10.1001/archopht.1990.01070040043027. No abstract available.
PMID: 2405826
citation: Dawson CR; Jones DB; Kaufman HE; Barron BA; Hauck WW; Wilhelmus KR; The Herpetic Eye Disease Study: Strategies of design and data analysis [Abstract]., Invest Ophthalmol Vis Sci 1990;31:553
citation: Dawson CR, Jones DB, Kaufman HE, Barron BA, Hauck WW, Wilhelmus KR. Design and organization of the herpetic eye disease study (HEDS). Curr Eye Res. 1991;10 Suppl:105-10. doi: 10.3109/02713689109020365.
PMID: 1864086
citation: Dawson CR; Jones DB; Wilhelmus KR; Kaufman HE; Barron BA; Hauck WW; Evaluation of corneal inflammatory disease: The Herpetic Eye Disease Study (HEDS) [Abstract]., Invest Ophthalmol Vis Sci 1991;32:1221
citation: Dawson CR; Hauck WW; Jones DB; Kaufman HE; Gee L; Barron BA; Wilhelmus KR; The Herpetic Eye Disease Study (HEDS). Clinical characteristics of randomized patients with herpetic stromal keratitis and iridocyclitis prior to initiating treatment [Abstract]., Invest Ophthalmol Vis 1992;33:1134
citation: Barron BA, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Wilhelmus KR, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of oral acyclovir for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1871-82. doi: 10.1016/s0161-6420(13)31155-5.
PMID: 7997323
citation: Wilhelmus KR, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Barron BA, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of topical corticosteroids for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1883-95; discussion 1895-6. doi: 10.1016/s0161-6420(94)31087-6.
PMID: 7997324
citation: A controlled trial of oral acyclovir for iridocyclitis caused by herpes simplex virus. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1996 Sep;114(9):1065-72. doi: 10.1001/archopht.1996.01100140267002.
PMID: 8790090
citation: Wilhelmus KR, Dawson CR, Barron BA, Bacchetti P, Gee L, Jones DB, Kaufman HE, Sugar J, Hyndiuk RA, Laibson PR, Stulting RD, Asbell PA. Risk factors for herpes simplex virus epithelial keratitis recurring during treatment of stromal keratitis or iridocyclitis. Herpetic Eye Disease Study Group. Br J Ophthalmol. 1996 Nov;80(11):969-72. doi: 10.1136/bjo.80.11.969.
PMID: 8976723
mesh term: Herpes Simplex
mesh term: Keratitis, Herpetic
mesh term: Keratitis
mesh term: Acyclovir
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
|
NCT0000xxxx/NCT00000139.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000139</url>
</required_header>
<id_info>
<org_study_id>NEI-38</org_study_id>
<nct_id>NCT00000139</nct_id>
</id_info>
<brief_title>Herpetic Eye Disease Study (HEDS) II</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV)
ulcerations of the corneal epithelium prevents progression to the blinding complications of
stromal keratitis and iridocyclitis.

To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye
infection in patients with previous episodes of herpetic eye disease.

To determine the role of external factors (such as ultraviolet light or corneal trauma) and
behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye
infections and disease.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Infection of the eye by herpes simplex virus (HSV) is a leading cause of corneal blindness in
the United States and other countries. The infection can lead to corneal scarring and
neovascularization, permanent endothelial dysfunction and corneal edema, secondary glaucoma,
and cataract. Despite the availability of topical antiviral agents that are highly active
against HSV keratitis, there is still no known effective method for reducing the frequency of
recurrence or severity of stromal keratitis and iridocyclitis. In addition, the prognosis is
poor for recovery of good vision following penetrating keratoplasty for actively inflamed or
highly vascularized herpetic corneas.

On the basis of both animal and human studies, the antiviral agent acyclovir may both treat
and prevent recurrence of HSV disease. However, no consensus yet exists on the use of
acyclovir in the management and prevention of herpetic eye disease.

HEDS-II consists of two randomized, placebo-controlled trials that are assessing the role of
oral acyclovir in the management of herpetic eye disease and one epidemiologic study that is
investigating risk factors, including stress, for the development of ocular recurrences of
the disease. The organizational structure consists of a national coordinating center, eight
regional coordinating clinical centers, and approximately 60 clinical sites. The clinical
sites where patients are enrolled and followed include both university-based and
community-based practices.

Herpes Simplex Virus Epithelial Keratitis Trial: HEDS-EKT evaluated the benefit of oral
acyclovir given during treatment of an acute HSV keratitis (dendritic or geographic
keratitis) in preventing the occurrence of later blinding complications. Patients entered the
trial within 7 days of onset. All patients received standard treatment with a topical
antiviral and were randomized to receive either oral acyclovir (400 mg five times a day for
21 days) or a placebo. Patients had eight visits within a 12-month followup period. The
primary outcome was the time to the first occurrence of stromal keratitis or iridocyclitis in
the study eye (eye with epithelial keratitis at time of study entry). The HEDS-EKT
recruitment goal was 502 patients.

Acyclovir Prevention Trial: HEDS-APT evaluated the benefit of long-term acyclovir treatment
in patients with a recent history of HSV eye disease but no current active disease. To be
eligible, a patient must have experienced any kind of ocular herpes simplex infection
(blepharitis, conjunctivitis, keratitis, or iridocyclitis) in the preceding year. The
infection must have been inactive and untreated for at least the previous 30 days. Patients
were randomized to receive either oral acyclovir (400 mg twice a day) or placebo for 1 year.
Five followup visits occurred during the 1-year treatment period and an additional three
followup visits during the 6-month post-treatment period. Episodes of recurrent HSV eye
disease during the trial were treated with topical corticosteroids and antivirals as
indicated, but patients continued to receive the oral acyclovir or placebo for the entire
365-day period. The primary outcome was the time to the first recurrence of any type of HSV
eye disease in either eye. The recruitment goal was 696 patients.

Ocular HSV Recurrence Factor Study: HEDS-RFS is evaluating the effect of psychological,
environmental, and biological factors on recurrences of herpetic eye disease. Patients
recruited into the HEDS-APT trial are eligible to participate in HEDS-RFS if they are 18
years or older. At entry, all subjects fill out a questionnaire to estimate the negative
affectivity trait measure. Subjects also fill out a short questionnaire every week for 52
weeks to track acute and chronic stressors (e.g., illnesses, injuries, menstrual periods, sun
exposure, emotional and financial stresses). The investigators ensure patient privacy by the
patient's mailing of the weekly logs directly to the HEDS National Coordinating Center.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>October 1992</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Keratitis, Herpetic</condition>
<condition>Ocular Herpes Simplex</condition>
<condition>Herpes Simplex</condition>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Stress</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Acyclovir</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Protocol-specific criteria are noted in the description above.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Francis I. Proctor Foundation, University of California, San Francisco</name>
<address>
<city>San Francisco</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory Eye Center</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Eye Center, University of Illinois, Chicago</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Louisiana State University Eye Center</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, The Mount Sinai Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wills Eye Hospital, Cornea Clinic</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cullen Eye Institute, Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Eye Institute, Medical College of Wisconsin</name>
<address>
<city>Milwaukee</city>
<state>Wisconsin</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/Hedsii.asp</url>
<description>NEI Press Release-Antiviral Drug Sharply Reduces Return of Herpes of the Eye</description>
</link>
<reference>
<citation>Dawson CR, Beck R, Wilhelmus KR, Cohen EJ. Herpetic eye disease study. You can help. Arch Ophthalmol. 1996 Jan;114(1):89-90. doi: 10.1001/archopht.1996.01100130085015. No abstract available.</citation>
<PMID>8540857</PMID>
</reference>
<reference>
<citation>A controlled trial of oral acyclovir for the prevention of stromal keratitis or iritis in patients with herpes simplex virus epithelial keratitis. The Epithelial Keratitis Trial. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1997 Jun;115(6):703-12. doi: 10.1001/archopht.1997.01100150705001. Erratum In: Arch Ophthalmol 1997 Sep;115(9):1196.</citation>
<PMID>9194719</PMID>
</reference>
<reference>
<citation>Acyclovir for the prevention of recurrent herpes simplex virus eye disease. Herpetic Eye Disease Study Group. N Engl J Med. 1998 Jul 30;339(5):300-6. doi: 10.1056/NEJM199807303390503.</citation>
<PMID>9696640</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>March 23, 2010</last_update_submitted>
<last_update_submitted_qc>March 23, 2010</last_update_submitted_qc>
<last_update_posted type="Estimate">March 24, 2010</last_update_posted>
<keyword>Herpes Simplex Stromal Keratitis</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Herpes Simplex</mesh_term>
<mesh_term>Keratitis, Herpetic</mesh_term>
<mesh_term>Keratitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Acyclovir</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000139
org study id: NEI-38
nct id: NCT00000139
lead sponsor:
To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV)
ulcerations of the corneal epithelium prevents progression to the blinding complications of
stromal keratitis and iridocyclitis.
To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye
infection in patients with previous episodes of herpetic eye disease.
To determine the role of external factors (such as ultraviolet light or corneal trauma) and
behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye
infections and disease.
Infection of the eye by herpes simplex virus (HSV) is a leading cause of corneal blindness in
the United States and other countries. The infection can lead to corneal scarring and
neovascularization, permanent endothelial dysfunction and corneal edema, secondary glaucoma,
and cataract. Despite the availability of topical antiviral agents that are highly active
against HSV keratitis, there is still no known effective method for reducing the frequency of
recurrence or severity of stromal keratitis and iridocyclitis. In addition, the prognosis is
poor for recovery of good vision following penetrating keratoplasty for actively inflamed or
highly vascularized herpetic corneas.
On the basis of both animal and human studies, the antiviral agent acyclovir may both treat
and prevent recurrence of HSV disease. However, no consensus yet exists on the use of
acyclovir in the management and prevention of herpetic eye disease.
HEDS-II consists of two randomized, placebo-controlled trials that are assessing the role of
oral acyclovir in the management of herpetic eye disease and one epidemiologic study that is
investigating risk factors, including stress, for the development of ocular recurrences of
the disease. The organizational structure consists of a national coordinating center, eight
regional coordinating clinical centers, and approximately 60 clinical sites. The clinical
sites where patients are enrolled and followed include both university-based and
community-based practices.
Herpes Simplex Virus Epithelial Keratitis Trial: HEDS-EKT evaluated the benefit of oral
acyclovir given during treatment of an acute HSV keratitis (dendritic or geographic
keratitis) in preventing the occurrence of later blinding complications. Patients entered the
trial within 7 days of onset. All patients received standard treatment with a topical
antiviral and were randomized to receive either oral acyclovir (400 mg five times a day for
21 days) or a placebo. Patients had eight visits within a 12-month followup period. The
primary outcome was the time to the first occurrence of stromal keratitis or iridocyclitis in
the study eye (eye with epithelial keratitis at time of study entry). The HEDS-EKT
recruitment goal was 502 patients.
Acyclovir Prevention Trial: HEDS-APT evaluated the benefit of long-term acyclovir treatment
in patients with a recent history of HSV eye disease but no current active disease. To be
eligible, a patient must have experienced any kind of ocular herpes simplex infection
(blepharitis, conjunctivitis, keratitis, or iridocyclitis) in the preceding year. The
infection must have been inactive and untreated for at least the previous 30 days. Patients
were randomized to receive either oral acyclovir (400 mg twice a day) or placebo for 1 year.
Five followup visits occurred during the 1-year treatment period and an additional three
followup visits during the 6-month post-treatment period. Episodes of recurrent HSV eye
disease during the trial were treated with topical corticosteroids and antivirals as
indicated, but patients continued to receive the oral acyclovir or placebo for the entire
365-day period. The primary outcome was the time to the first recurrence of any type of HSV
eye disease in either eye. The recruitment goal was 696 patients.
Ocular HSV Recurrence Factor Study: HEDS-RFS is evaluating the effect of psychological,
environmental, and biological factors on recurrences of herpetic eye disease. Patients
recruited into the HEDS-APT trial are eligible to participate in HEDS-RFS if they are 18
years or older. At entry, all subjects fill out a questionnaire to estimate the negative
affectivity trait measure. Subjects also fill out a short questionnaire every week for 52
weeks to track acute and chronic stressors (e.g., illnesses, injuries, menstrual periods, sun
exposure, emotional and financial stresses). The investigators ensure patient privacy by the
patient's mailing of the weekly logs directly to the HEDS National Coordinating Center.
allocation: Randomized
primary purpose: Treatment
intervention type: Behavioral
intervention name: Stress
intervention type: Drug
intervention name: Acyclovir
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/news/pressreleases/Hedsii.asp
description: NEI Press Release-Antiviral Drug Sharply Reduces Return of Herpes of the Eye
citation: Dawson CR, Beck R, Wilhelmus KR, Cohen EJ. Herpetic eye disease study. You can help. Arch Ophthalmol. 1996 Jan;114(1):89-90. doi: 10.1001/archopht.1996.01100130085015. No abstract available.
PMID: 8540857
citation: A controlled trial of oral acyclovir for the prevention of stromal keratitis or iritis in patients with herpes simplex virus epithelial keratitis. The Epithelial Keratitis Trial. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1997 Jun;115(6):703-12. doi: 10.1001/archopht.1997.01100150705001. Erratum In: Arch Ophthalmol 1997 Sep;115(9):1196.
PMID: 9194719
citation: Acyclovir for the prevention of recurrent herpes simplex virus eye disease. Herpetic Eye Disease Study Group. N Engl J Med. 1998 Jul 30;339(5):300-6. doi: 10.1056/NEJM199807303390503.
PMID: 9696640
mesh term: Herpes Simplex
mesh term: Keratitis, Herpetic
mesh term: Keratitis
mesh term: Acyclovir
|
NCT0000xxxx/NCT00000140.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000140</url>
</required_header>
<id_info>
<org_study_id>NEI-39</org_study_id>
<nct_id>NCT00000140</nct_id>
</id_info>
<brief_title>The Silicone Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare, through a randomized, multicenter surgical trial, the postoperative tamponade
effectiveness of intraocular silicone oil with that of an intraocular long-acting gas
(initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management
of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy
and associated techniques.

To evaluate the ocular complications that result from the use of silicone oil and gas.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The treatment of retinal detachment complicated by PVR remains controversial. Although some
cases are managed successfully by pars plana vitrectomy and with temporary tamponade provided
by intraocular gas, others eventually redetach with this technique. Preliminary reports
indicate that prolonged tamponade with liquid silicone results in improved anatomical
success, but the eventual visual outcome may be prejudiced by silicone-related complications,
particularly glaucoma and keratopathy. The addition of hydraulic reattachment by simultaneous
fluid/gas exchange to vitrectomy surgery has proved to be an important development. Although
complications are few with these procedures, subsequent redetachment is frequent.

The Silicone Study was a randomized trial to investigate the relative merits of silicone oil
or gas as tamponade modalities. All study patients underwent vitrectomy and were randomized
intraoperatively either to silicone oil or to gas. Two groups of eyes were entered into the
study: eyes that had not had a prior vitrectomy (Group 1) and those that had undergone
previous vitrectomy outside the study (Group 2).

A critical element in the study was a standardized surgical procedure for PVR. This surgical
procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by
assessment of the relief provided by an intraocular air tamponade. The eye was randomized to
silicone oil or gas only after completion of the entire surgical procedure to eliminate
investigator bias that might develop through knowledge of the treatment modality. Patients
were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and
36 months after that date. Repeated surgery was permitted for either treatment modality. The
Fundus Photograph Reading Center staff processed and analyzed photographs taken at all the
clinics, graded the preoperative severity of PVR on the basis of baseline visit photographs,
and confirmed the macular status at followup visits.

End points of the study were visual acuity of 5/200 or greater and macular reattachment for 6
months following the final surgical procedure. The successful outcomes and complication rates
of the two modalities were compared.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1985</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Proliferative Vitreoretinopathy</condition>
<condition>Retinal Detachment</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Perfluoropropane</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Sulfur Hexafluoride</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Silicone Oil</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according
to the Retina Society Classification and visual acuity of light perception or better.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Lean JS. Changing attitudes in United States to use of intravitreal silicone. Jpn J Ophthalmol. 1987;31(1):132-7.</citation>
<PMID>3626172</PMID>
</reference>
<reference>
<citation>Glaser BM. Silicone oil for proliferative vitreoretinopathy. Does it help or hinder? Arch Ophthalmol. 1988 Mar;106(3):323-4. doi: 10.1001/archopht.1988.01060130349017. No abstract available.</citation>
<PMID>3345147</PMID>
</reference>
<reference>
<citation>Azen SP, Irvine AR, Davis MD, Stern W, Lonn L, Hilton G, Schwartz A, Boone D, Quillen-Thomas B, Lyons M, et al. The validity and reliability of photographic documentation of proliferative vitreoretinopathy. Ophthalmology. 1989 Mar;96(3):352-7. doi: 10.1016/s0161-6420(89)32895-8.</citation>
<PMID>2652029</PMID>
</reference>
<reference>
<citation>Boone DC; Lai M; Azen S; Silicone Study Group; Clinical judgment and centralized data management., Controlled Clin Trials 1989;10:339</citation>
</reference>
<reference>
<citation>Irvine AR; Photographic documentation and grading of PVR, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989:105-109</citation>
</reference>
<reference>
<citation>Lean JS, Stern WH, Irvine AR, Azen SP. Classification of proliferative vitreoretinopathy used in the silicone study. The Silicone Study Group. Ophthalmology. 1989 Jun;96(6):765-71. doi: 10.1016/s0161-6420(89)32821-1.</citation>
<PMID>2662099</PMID>
</reference>
<reference>
<citation>Barlow W, Azen S. The effect of therapeutic treatment crossovers on the power of clinical trials. The Silicone Study Group. Control Clin Trials. 1990 Oct;11(5):314-26. doi: 10.1016/0197-2456(90)90173-y.</citation>
<PMID>1963127</PMID>
</reference>
<reference>
<citation>Stern WH; Lean JS; Silicone Study Group; Intraocular silicone oil versus gas in the management of proliferative vitreoretinopathy (PVR): A multicenter clinical study, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989</citation>
</reference>
<reference>
<citation>Azen SP, Boone DC, Barlow W, McCuen BW, Walonker AF, Anderson MM, Lean JS, Mowery RL, Ryan SJ, Stern W. Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study. Control Clin Trials. 1991 Jun;12(3):438-55. doi: 10.1016/0197-2456(91)90022-e.</citation>
<PMID>1651213</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Detachment</mesh_term>
<mesh_term>Vitreoretinopathy, Proliferative</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000140
org study id: NEI-39
nct id: NCT00000140
lead sponsor:
To compare, through a randomized, multicenter surgical trial, the postoperative tamponade
effectiveness of intraocular silicone oil with that of an intraocular long-acting gas
(initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management
of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy
and associated techniques.
To evaluate the ocular complications that result from the use of silicone oil and gas.
The treatment of retinal detachment complicated by PVR remains controversial. Although some
cases are managed successfully by pars plana vitrectomy and with temporary tamponade provided
by intraocular gas, others eventually redetach with this technique. Preliminary reports
indicate that prolonged tamponade with liquid silicone results in improved anatomical
success, but the eventual visual outcome may be prejudiced by silicone-related complications,
particularly glaucoma and keratopathy. The addition of hydraulic reattachment by simultaneous
fluid/gas exchange to vitrectomy surgery has proved to be an important development. Although
complications are few with these procedures, subsequent redetachment is frequent.
The Silicone Study was a randomized trial to investigate the relative merits of silicone oil
or gas as tamponade modalities. All study patients underwent vitrectomy and were randomized
intraoperatively either to silicone oil or to gas. Two groups of eyes were entered into the
study: eyes that had not had a prior vitrectomy (Group 1) and those that had undergone
previous vitrectomy outside the study (Group 2).
A critical element in the study was a standardized surgical procedure for PVR. This surgical
procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by
assessment of the relief provided by an intraocular air tamponade. The eye was randomized to
silicone oil or gas only after completion of the entire surgical procedure to eliminate
investigator bias that might develop through knowledge of the treatment modality. Patients
were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and
36 months after that date. Repeated surgery was permitted for either treatment modality. The
Fundus Photograph Reading Center staff processed and analyzed photographs taken at all the
clinics, graded the preoperative severity of PVR on the basis of baseline visit photographs,
and confirmed the macular status at followup visits.
End points of the study were visual acuity of 5/200 or greater and macular reattachment for 6
months following the final surgical procedure. The successful outcomes and complication rates
of the two modalities were compared.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Perfluoropropane
intervention type: Drug
intervention name: Sulfur Hexafluoride
intervention type: Drug
intervention name: Silicone Oil
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Lean JS. Changing attitudes in United States to use of intravitreal silicone. Jpn J Ophthalmol. 1987;31(1):132-7.
PMID: 3626172
citation: Glaser BM. Silicone oil for proliferative vitreoretinopathy. Does it help or hinder? Arch Ophthalmol. 1988 Mar;106(3):323-4. doi: 10.1001/archopht.1988.01060130349017. No abstract available.
PMID: 3345147
citation: Azen SP, Irvine AR, Davis MD, Stern W, Lonn L, Hilton G, Schwartz A, Boone D, Quillen-Thomas B, Lyons M, et al. The validity and reliability of photographic documentation of proliferative vitreoretinopathy. Ophthalmology. 1989 Mar;96(3):352-7. doi: 10.1016/s0161-6420(89)32895-8.
PMID: 2652029
citation: Boone DC; Lai M; Azen S; Silicone Study Group; Clinical judgment and centralized data management., Controlled Clin Trials 1989;10:339
citation: Irvine AR; Photographic documentation and grading of PVR, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989:105-109
citation: Lean JS, Stern WH, Irvine AR, Azen SP. Classification of proliferative vitreoretinopathy used in the silicone study. The Silicone Study Group. Ophthalmology. 1989 Jun;96(6):765-71. doi: 10.1016/s0161-6420(89)32821-1.
PMID: 2662099
citation: Barlow W, Azen S. The effect of therapeutic treatment crossovers on the power of clinical trials. The Silicone Study Group. Control Clin Trials. 1990 Oct;11(5):314-26. doi: 10.1016/0197-2456(90)90173-y.
PMID: 1963127
citation: Stern WH; Lean JS; Silicone Study Group; Intraocular silicone oil versus gas in the management of proliferative vitreoretinopathy (PVR): A multicenter clinical study, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989
citation: Azen SP, Boone DC, Barlow W, McCuen BW, Walonker AF, Anderson MM, Lean JS, Mowery RL, Ryan SJ, Stern W. Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study. Control Clin Trials. 1991 Jun;12(3):438-55. doi: 10.1016/0197-2456(91)90022-e.
PMID: 1651213
mesh term: Retinal Detachment
mesh term: Vitreoretinopathy, Proliferative
|
NCT0000xxxx/NCT00000142.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000142</url>
</required_header>
<id_info>
<org_study_id>NEI-41</org_study_id>
<nct_id>NCT00000142</nct_id>
</id_info>
<brief_title>Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)</brief_title>
<acronym>HPCRT</acronym>
<official_title>Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>Baylor College of Medicine</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Johns Hopkins University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Louisiana State University Health Sciences Center in New Orleans</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Icahn School of Medicine at Mount Sinai</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>New Jersey Medical School</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>NYU Langone Health</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Northwestern University</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Diego</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of California, San Francisco</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of Miami</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of North Carolina, Chapel Hill</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>University of South Florida</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously
known as HPMPC) for the treatment of retinitis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
CMV (cytomegalovirus) retinitis is the most common intraocular infection in patients with
AIDS and is estimated to affect 35 percent to 40 percent of patients with AIDS. Untreated CMV
(cytomegalovirus) retinitis is a progressive disorder, the end result of which is total
retinal destruction and blindness. As of September 1997, drugs approved by the United States
Food and Drug Administration (FDA) for the treatment of CMV (cytomegalovirus)retinitis were
ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). Cidofovir has a
prolonged duration of effect permitting intermittent administration. All systemically
administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week
high-dose treatment (induction) to control the infection followed by long-term lower dose
treatment (maintenance) to prevent relapse. Cidofovir is administered as an intravenous
infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy. The
HPCRT evaluated the efficacy and safety of cidofovir therapy.

The HPCRT was a multicenter, randomized, controlled clinical trial of cidofovir for the
treatment of CMV (cytomegalovirus) retinitis. Patients with small peripheral CMV
(cytomegalovirus) retinitis lesions (i.e., not at risk of immediate loss of visual acuity)
were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis
had progressed. Patients randomized to immediate therapy received either 1) low-dose
cidofovir at 5 mg/kg once weekly induction for 2 weeks, followed by 3 mg/kg once every 2
weeks for maintenance or 2) high-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks
followed by 5 mg/kg once every 2 weeks for maintenance. Patients whose retinitis progressed
were given treatment according to best medical judgement, and those assigned to deferral were
generally treated with cidofovir.

Outcomes in this trial included retinitis progression, loss of retinal area, and morbidity.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>April 1994</start_date>
<completion_date type="Actual">February 1996</completion_date>
<primary_completion_date type="Actual">February 1996</primary_completion_date>
<phase>Phase 2/Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Survival</measure>
<time_frame>All patients enrolled will be followed until a common study closing date</time_frame>
</primary_outcome>
<number_of_arms>3</number_of_arms>
<enrollment type="Actual">64</enrollment>
<condition>HIV Infections</condition>
<condition>CMV Cytomegalovirus Retinitis</condition>
<arm_group>
<arm_group_label>treatment deferral</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</arm_group>
<arm_group>
<arm_group_label>Cidofovir (low dose)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks</description>
</arm_group>
<arm_group>
<arm_group_label>Cidofovir (high dose)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cidofovir</intervention_name>
<description>Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
<arm_group_label>Cidofovir (high dose)</arm_group_label>
<arm_group_label>Cidofovir (low dose)</arm_group_label>
<arm_group_label>treatment deferral</arm_group_label>
<other_name>Vistide</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC)

- 13 years or older

- Diagnosis of CMV (cytomegalovirus) retinitis as determined by a SOCA-certified
Ophthalmologist.

- At least one lesion whose size is one-quarter disc area or more that can be
photographed.

- Visual acuity in an affected eye of 3 or more lines on the (ETDRS) Early Treatment
Diabetic Retinopathy Study chart at 1 meter distance (Snellen equivalent 8/200).

- score of 60 or more on the Karnofsky scale.

- Serum creatinine of 1.5mg/dL or less

- less than 1+ proteinuria on urinalysis

- Total bilirubin of 3.0 mg/dL or less

- Hepatic transaminase levels that do not exceed 5 times the normal levels

- Absolute neutrophil count of 750 cells/µL or greater

- Platelet count of 50,000 cells/µL or greater

- Hemoglobin of 7.5 g/dL or greater

- Negative pregnancy test (females of childbearing potential)

- All men/women of childbearing potential should practice birth control to prevent
pregnancy while on study and for 3 months afterwards

- Willingness/ability, with the assistance of a caregiver if necessary to comply with
treatment and follow-up procedures

- Signed consent statement

Exclusion criteria:

- Evidence of a CMV (cytomegalovirus) retinitis lesion within zone 1. A lesion less than
1,500 µ from the margin of the optic disc or less than 3,000 µ from the center of the
fovea in either eye excludes a patient.

- Evidence of a CMV retinitis lesions that involves 25% or more of the retinal area
regardless of location.

- Previous or ongoing therapy for CMV (cytomegalovirus) disease with ganciclovir,
foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents solely as
prophylaxis are eligible for enrollment.

- Retinal detachment(s) in the affected eye(s)

- media opacity that precludes visualization of the fundus of both eyes.

- patients with a diagnosis of extraocular CMV (cytomegalovirus) disease.

- Patients with history of clinically significant renal disease or renal dialysis.

- Patients with history of clinically significant cardiac disease, including symptoms of
ischemia, congestive heart failure, or arrhythmia.

- pregnant or lactating

- patients with active medical problems including drug or alcohol abuse which could
hinder compliance with treatment or follow-up procedures.

- patients receiving therapy within the previous 7 days with nephrotoxic drugs,
including: Amphotericin B, Vidarabine, Aminoglycoside antibiotics, Intravenous
pentamidine. Patients receiving any of these drugs must discontinue the drug(s) at
least one week prior to the time of enrollment, and for the duration of the trial
period.

- history of clinically significant probenecid allergy.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Douglas Jabs, MD</last_name>
<role>Study Chair</role>
<affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
</overall_official>
<reference>
<citation>Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.</citation>
<PMID>9036798</PMID>
</reference>
<reference>
<citation>Long-term follow-up of patients with AIDS treated with parenteral cidofovir for cytomegalovirus retinitis: the HPMPC Peripheral Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. AIDS. 2000 Jul 28;14(11):1571-81.</citation>
<PMID>10983644</PMID>
</reference>
<reference>
<citation>Kravcik S. Cidofovir for cytomegalovirus retinitis. Ann Intern Med. 1997 Sep 15;127(6):490-1. doi: 10.7326/0003-4819-127-6-199709150-00015. No abstract available.</citation>
<PMID>9313009</PMID>
</reference>
<verification_date>July 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>June 2, 2015</results_first_submitted>
<results_first_submitted_qc>October 14, 2015</results_first_submitted_qc>
<results_first_posted type="Estimate">November 17, 2015</results_first_posted>
<last_update_submitted>October 14, 2015</last_update_submitted>
<last_update_submitted_qc>October 14, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">November 17, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cidofovir</mesh_term>
</intervention_browse>
<clinical_results>
<participant_flow>
<recruitment_details>April 1994</recruitment_details>
<group_list>
<group group_id="P1">
<title>Treatment Deferral</title>
<description>IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="P2">
<title>Cidofovir (Low Dose)</title>
<description>5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="P3">
<title>Cidofovir (High Dose)</title>
<description>5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="26"/>
<participants group_id="P2" count="26"/>
<participants group_id="P3" count="12"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="26"/>
<participants group_id="P2" count="26"/>
<participants group_id="P3" count="12"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
<participants group_id="P3" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>Treatment Deferral</title>
<description>IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="B2">
<title>Cidofovir (Low Dose)</title>
<description>5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="B3">
<title>Cidofovir (High Dose)</title>
<description>5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="B4">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="26"/>
<count group_id="B2" value="26"/>
<count group_id="B3" value="12"/>
<count group_id="B4" value="64"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="0"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="26"/>
<measurement group_id="B2" value="26"/>
<measurement group_id="B3" value="12"/>
<measurement group_id="B4" value="64"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
<measurement group_id="B4" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="2"/>
<measurement group_id="B2" value="2"/>
<measurement group_id="B3" value="1"/>
<measurement group_id="B4" value="5"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="24"/>
<measurement group_id="B2" value="24"/>
<measurement group_id="B3" value="11"/>
<measurement group_id="B4" value="59"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Survival</title>
<time_frame>All patients enrolled will be followed until a common study closing date</time_frame>
<group_list>
<group group_id="O1">
<title>Treatment Deferral</title>
<description>IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="O2">
<title>Cidofovir (Low Dose)</title>
<description>5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="O3">
<title>Cidofovir (High Dose)</title>
<description>5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
</group_list>
<measure>
<title>Survival</title>
<units>participants</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="26"/>
<count group_id="O2" value="26"/>
<count group_id="O3" value="12"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<title>mortality</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="6"/>
<measurement group_id="O2" value="7"/>
<measurement group_id="O3" value="3"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>progression</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="20"/>
<measurement group_id="O2" value="17"/>
<measurement group_id="O3" value="5"/>
</measurement_list>
</category>
</category_list>
</class>
<class>
<title>va loss of 15 letters</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="4"/>
<measurement group_id="O2" value="6"/>
<measurement group_id="O3" value="2"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>1 year, 10 months</time_frame>
<group_list>
<group group_id="E1">
<title>Treatment Deferral</title>
<description>IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="E2">
<title>Cidofovir (Low Dose)</title>
<description>5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
<group group_id="E3">
<title>Cidofovir (High Dose)</title>
<description>5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
Cidofovir: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.</description>
</group>
</group_list>
<serious_events>
<default_assessment>Non-systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
<counts group_id="E2" subjects_affected="13" subjects_at_risk="26"/>
<counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
</event>
</event_list>
</category>
<category>
<title>Blood and lymphatic system disorders</title>
<event_list>
<event>
<sub_title>Proteinuria 2+</sub_title>
<counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="26"/>
<counts group_id="E2" events="21" subjects_affected="13" subjects_at_risk="26"/>
<counts group_id="E3" events="25" subjects_affected="8" subjects_at_risk="12"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>5</frequency_threshold>
<default_assessment>Non-systematic Assessment</default_assessment>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
<counts group_id="E2" subjects_affected="2" subjects_at_risk="26"/>
<counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
</event>
</event_list>
</category>
<category>
<title>Blood and lymphatic system disorders</title>
<event_list>
<event>
<sub_title>Serum creatinine level >= 133 umol/L (1.5 mg/dL)</sub_title>
<counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="26"/>
<counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
<counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="12"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Dr. Curtis Meinert</name_or_title>
<organization>Johns Hopkins Bloomberg School of Public Health</organization>
<phone>410-955-8175</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000142
org study id: NEI-41
nct id: NCT00000142
lead sponsor:
collaborator:
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collaborator:
has dmc: Yes
To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously
known as HPMPC) for the treatment of retinitis.
CMV (cytomegalovirus) retinitis is the most common intraocular infection in patients with
AIDS and is estimated to affect 35 percent to 40 percent of patients with AIDS. Untreated CMV
(cytomegalovirus) retinitis is a progressive disorder, the end result of which is total
retinal destruction and blindness. As of September 1997, drugs approved by the United States
Food and Drug Administration (FDA) for the treatment of CMV (cytomegalovirus)retinitis were
ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). Cidofovir has a
prolonged duration of effect permitting intermittent administration. All systemically
administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week
high-dose treatment (induction) to control the infection followed by long-term lower dose
treatment (maintenance) to prevent relapse. Cidofovir is administered as an intravenous
infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy. The
HPCRT evaluated the efficacy and safety of cidofovir therapy.
The HPCRT was a multicenter, randomized, controlled clinical trial of cidofovir for the
treatment of CMV (cytomegalovirus) retinitis. Patients with small peripheral CMV
(cytomegalovirus) retinitis lesions (i.e., not at risk of immediate loss of visual acuity)
were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis
had progressed. Patients randomized to immediate therapy received either 1) low-dose
cidofovir at 5 mg/kg once weekly induction for 2 weeks, followed by 3 mg/kg once every 2
weeks for maintenance or 2) high-dose cidofovir at 5 mg/kg once weekly induction for 2 weeks
followed by 5 mg/kg once every 2 weeks for maintenance. Patients whose retinitis progressed
were given treatment according to best medical judgement, and those assigned to deferral were
generally treated with cidofovir.
Outcomes in this trial included retinitis progression, loss of retinal area, and morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: All patients enrolled will be followed until a common study closing date
arm group label: treatment deferral
arm group type: Experimental
description: IV (in the vein) treatment deferred until retinitis progressed, either:
5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or
5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
arm group label: Cidofovir (low dose)
arm group type: Experimental
description: 5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks
arm group label: Cidofovir (high dose)
arm group type: Experimental
description: 5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
intervention type: Drug
intervention name: Cidofovir
description: Three groups:
the deferral group, treatment deferred until retinitis progressed
Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.
High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.
arm group label: Cidofovir (high dose)
arm group label: Cidofovir (low dose)
arm group label: treatment deferral
other name: Vistide
criteria:
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas Jabs, MD
role: Study Chair
affiliation: Icahn School of Medicine at Mount Sinai
citation: Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.
PMID: 9036798
citation: Long-term follow-up of patients with AIDS treated with parenteral cidofovir for cytomegalovirus retinitis: the HPMPC Peripheral Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. AIDS. 2000 Jul 28;14(11):1571-81.
PMID: 10983644
citation: Kravcik S. Cidofovir for cytomegalovirus retinitis. Ann Intern Med. 1997 Sep 15;127(6):490-1. doi: 10.7326/0003-4819-127-6-199709150-00015. No abstract available.
PMID: 9313009
responsible party type: Sponsor
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Cidofovir
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000143.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000143</url>
</required_header>
<id_info>
<org_study_id>NEI-42</org_study_id>
<nct_id>NCT00000143</nct_id>
</id_info>
<brief_title>Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)</brief_title>
<acronym>GCCRT</acronym>
<official_title>Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir
intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.

To compare a treatment regimen that incorporates highly active local therapy (ganciclovir
device) with a treatment regimen that does not.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in
patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is
estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS
and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in
these patients, making CMV retinitis the most common ocular infection encountered. CMV
retinitis is a relatively late-stage manifestation, associated with cluster of
differentiation 4 (CD4) + T-cell counts < 100 cells/µL and often < 50 cells/µL.

All currently available treatments for CMV suppress viral replication but do not eliminate
the virus from the body. Discontinuation of therapy is associated with a prompt relapse of
the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis
generally occurs, at least with systemically administered anti-CMV drugs.

The first two treatments approved for CMV retinitis were intravenous ganciclovir and
intravenous foscarnet. Both are given by daily intravenous infusions and therefore require
central venous catheters. The development of newer treatments has focused not only on
efficacious treatments, but also on treatments that do not require central venous catheters.
Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and
intravenous cidofovir.

In vitro data suggest that combination therapies are synergistic in inhibiting viral
replication; these therapies include a foscarnet-ganciclovir combination and a
cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the
combination of intravenous ganciclovir and foscarnet was more effective than either drug
alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent
intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed
disease because it may provide synergy for controlling both ocular and visceral disease while
not necessitating either a central venous catheter or an intraocular surgical procedure.

The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical
trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular
device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be
surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis.
Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be
administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2
weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients
will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per
day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate
that regimen, an alternative systemic regimen will be recommended.

Study outcome variables include a decrease of three or more lines from baseline in best
corrected visual acuity and rate of visual field loss. The study will also assess other
variables including mortality, blood CMV and HIV load, quality of life, and medical costs.

Treatment assignment will not be masked to either patients or clinicians; however, reading of
fundus photographs to determine both change in retinal involvement and progression will be
masked.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1997</start_date>
<completion_date type="Actual">June 2000</completion_date>
<primary_completion_date type="Actual">June 2000</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Survival</measure>
<time_frame>3 years</time_frame>
</primary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">61</enrollment>
<condition>Cytomegalovirus Retinitis</condition>
<condition>HIV Infections</condition>
<arm_group>
<arm_group_label>Ganciclovir implant and oral ganciclovir</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily</description>
</arm_group>
<arm_group>
<arm_group_label>Cidofovir IV (Intravenous)</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week</description>
</arm_group>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Ganciclovir implant and oral ganciclovir</intervention_name>
<description>oral ganciclovir, 1 gm three times daily</description>
<arm_group_label>Ganciclovir implant and oral ganciclovir</arm_group_label>
<other_name>Vitraset</other_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cidofovir intravenous</intervention_name>
<description>intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week</description>
<arm_group_label>Cidofovir IV (Intravenous)</arm_group_label>
<other_name>Vistide</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion criteria:

- Age 13 years or older

- Diagnosis of AIDS according to current Centers for Disease Control and Prevention
(CDC) definition

- Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of
any zone or amount of retina is allowed)

- Best corrected visual acuity of 20/100 or better in at least one eye

- At least one lesion 750 cells/µL or greater

- Platelet count 50,000 cells/µL or greater

- Willingness and ability, with the assistance of a caregiver if necessary to comply
with treatment and follow up procedures

- Willingness of all men and women of childbearing potential to practice adequate birth
control to prevent pregnancies during the study and for 3 months afterwards

- Collection of all baseline data within 5 days prior to randomization

- Signed consent statement

Exclusion criteria:

- Media opacities that preclude visualization of the fundus of all otherwise eligible
eyes

- Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months
of study entry

- Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment
or follow up procedures

- Unwillingness to refrain from breast-feeding during the study and for 3 months
afterwards
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Douglas Jabs, MD</last_name>
<role>Study Chair</role>
<affiliation>SOCA Chairman's Office</affiliation>
</overall_official>
<location>
<facility>
<name>Department of Ophthalmology, University of California, Irvine</name>
<address>
<city>Irvine</city>
<state>California</state>
<zip>92697-4375</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Shiley Eye Center Center, 0946, University of California, San Diego</name>
<address>
<city>La Jolla</city>
<state>California</state>
<zip>92093-0946</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>LAC/USC Medical Center, 5P21 Rand Schrader Clinic</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jules Stein Eye Institute, University of California, Los Angeles</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095-7003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Beckman Vision Center, University of California, San Francisco</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94143</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bascom Palmer Eye Institute, University of Miami</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33136</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida, MDC Box 21</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612-4799</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Emory Clinic, Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30322</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Division of Infectious Diseases, Indiana University, Indianapolis</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202-2879</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>LSU Eye Center, Louisiana State University Medical Center</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<zip>70112</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287-9217</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Harvard/BCH AIDS Clinical Trials Unit, Massachusetts General Hospital</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UMDNJ-New Jersey Medical School</name>
<address>
<city>Newark</city>
<state>New Jersey</state>
<zip>07103-2499</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, New York University Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, New York Hospital-Cornell Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10021</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology, Mount Sinai School of Medicine</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029-6574</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of North Carolina at Chapel Hill</name>
<address>
<city>Chapel Hill</city>
<state>North Carolina</state>
<zip>27599-7030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cullen Eye Institute, Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Studies of Ocular Complications of AIDS Research Group. The AIDS Clinical Trials Group.. The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol. 2001 Apr;131(4):457-67. doi: 10.1016/s0002-9394(01)00840-6.</citation>
<PMID>11292409</PMID>
</reference>
<reference>
<citation>Dunn JP, Van Natta M, Foster G, Kuppermann BD, Martin DF, Zong A, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis: the Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Retina. 2004 Feb;24(1):41-50. doi: 10.1097/00006982-200402000-00007.</citation>
<PMID>15076943</PMID>
</reference>
<verification_date>July 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<results_first_submitted>July 1, 2015</results_first_submitted>
<results_first_submitted_qc>February 18, 2016</results_first_submitted_qc>
<results_first_posted type="Estimate">March 14, 2016</results_first_posted>
<last_update_submitted>February 18, 2016</last_update_submitted>
<last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">March 14, 2016</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ganciclovir</mesh_term>
<mesh_term>Ganciclovir triphosphate</mesh_term>
<mesh_term>Cidofovir</mesh_term>
</intervention_browse>
<patient_data>
<sharing_ipd>Yes</sharing_ipd>
</patient_data>
<clinical_results>
<participant_flow>
<recruitment_details>June 1997</recruitment_details>
<group_list>
<group group_id="P1">
<title>Ganciclovir Implant and Oral Ganciclovir</title>
<description>Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily</description>
</group>
<group group_id="P2">
<title>Cidofovir IV (Intravenous)</title>
<description>cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week</description>
</group>
</group_list>
<period_list>
<period>
<title>Overall Study</title>
<milestone_list>
<milestone>
<title>STARTED</title>
<participants_list>
<participants group_id="P1" count="31"/>
<participants group_id="P2" count="30"/>
</participants_list>
</milestone>
<milestone>
<title>COMPLETED</title>
<participants_list>
<participants group_id="P1" count="31"/>
<participants group_id="P2" count="30"/>
</participants_list>
</milestone>
<milestone>
<title>NOT COMPLETED</title>
<participants_list>
<participants group_id="P1" count="0"/>
<participants group_id="P2" count="0"/>
</participants_list>
</milestone>
</milestone_list>
</period>
</period_list>
</participant_flow>
<baseline>
<group_list>
<group group_id="B1">
<title>Ganciclovir Implant and Oral Ganciclovir</title>
<description>Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily</description>
</group>
<group group_id="B2">
<title>Cidofovir IV (Intravenous)</title>
<description>cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week</description>
</group>
<group group_id="B3">
<title>Total</title>
<description>Total of all reporting groups</description>
</group>
</group_list>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Overall</scope>
<count_list>
<count group_id="B1" value="31"/>
<count group_id="B2" value="30"/>
<count group_id="B3" value="61"/>
</count_list>
</analyzed>
</analyzed_list>
<measure_list>
<measure>
<title>Age</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title><=18 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
<category>
<title>Between 18 and 65 years</title>
<measurement_list>
<measurement group_id="B1" value="31"/>
<measurement group_id="B2" value="30"/>
<measurement group_id="B3" value="61"/>
</measurement_list>
</category>
<category>
<title>>=65 years</title>
<measurement_list>
<measurement group_id="B1" value="0"/>
<measurement group_id="B2" value="0"/>
<measurement group_id="B3" value="0"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Sex: Female, Male</title>
<units>Participants</units>
<param>Count of Participants</param>
<class_list>
<class>
<category_list>
<category>
<title>Female</title>
<measurement_list>
<measurement group_id="B1" value="7"/>
<measurement group_id="B2" value="5"/>
<measurement group_id="B3" value="12"/>
</measurement_list>
</category>
<category>
<title>Male</title>
<measurement_list>
<measurement group_id="B1" value="24"/>
<measurement group_id="B2" value="25"/>
<measurement group_id="B3" value="49"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
<measure>
<title>Region of Enrollment</title>
<units>participants</units>
<param>Number</param>
<class_list>
<class>
<title>United States</title>
<category_list>
<category>
<measurement_list>
<measurement group_id="B1" value="31"/>
<measurement group_id="B2" value="30"/>
<measurement group_id="B3" value="61"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</measure_list>
</baseline>
<outcome_list>
<outcome>
<type>Primary</type>
<title>Survival</title>
<time_frame>3 years</time_frame>
<group_list>
<group group_id="O1">
<title>Ganciclovir Implant and Oral Ganciclovir</title>
<description>Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily</description>
</group>
<group group_id="O2">
<title>Cidofovir IV (Intravenous)</title>
<description>cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week</description>
</group>
</group_list>
<measure>
<title>Survival</title>
<units>participants</units>
<param>Number</param>
<analyzed_list>
<analyzed>
<units>Participants</units>
<scope>Measure</scope>
<count_list>
<count group_id="O1" value="31"/>
<count group_id="O2" value="30"/>
</count_list>
</analyzed>
</analyzed_list>
<class_list>
<class>
<category_list>
<category>
<measurement_list>
<measurement group_id="O1" value="31"/>
<measurement group_id="O2" value="30"/>
</measurement_list>
</category>
</category_list>
</class>
</class_list>
</measure>
</outcome>
</outcome_list>
<reported_events>
<time_frame>3 years</time_frame>
<group_list>
<group group_id="E1">
<title>Ganciclovir Implant and Oral Ganciclovir</title>
<description>Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily</description>
</group>
<group group_id="E2">
<title>Cidofovir IV (Intravenous)</title>
<description>cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week</description>
</group>
</group_list>
<serious_events>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, serious adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
</event>
</event_list>
</category>
</category_list>
</serious_events>
<other_events>
<frequency_threshold>0</frequency_threshold>
<category_list>
<category>
<title>Total</title>
<event_list>
<event>
<sub_title>Total, other adverse events</sub_title>
<counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
<counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
</event>
</event_list>
</category>
</category_list>
</other_events>
</reported_events>
<certain_agreements>
<pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
<restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
</certain_agreements>
<point_of_contact>
<name_or_title>Curtis Meinert, PhD</name_or_title>
<organization>Johns Hopkins School of Public Health</organization>
<phone>410-955-8198</phone>
<email>[email protected]</email>
</point_of_contact>
</clinical_results>
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000143
org study id: NEI-42
nct id: NCT00000143
lead sponsor:
has dmc: Yes
To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir
intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.
To compare a treatment regimen that incorporates highly active local therapy (ganciclovir
device) with a treatment regimen that does not.
Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in
patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is
estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS
and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in
these patients, making CMV retinitis the most common ocular infection encountered. CMV
retinitis is a relatively late-stage manifestation, associated with cluster of
differentiation 4 (CD4) + T-cell counts < 100 cells/µL and often < 50 cells/µL.
All currently available treatments for CMV suppress viral replication but do not eliminate
the virus from the body. Discontinuation of therapy is associated with a prompt relapse of
the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis
generally occurs, at least with systemically administered anti-CMV drugs.
The first two treatments approved for CMV retinitis were intravenous ganciclovir and
intravenous foscarnet. Both are given by daily intravenous infusions and therefore require
central venous catheters. The development of newer treatments has focused not only on
efficacious treatments, but also on treatments that do not require central venous catheters.
Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and
intravenous cidofovir.
In vitro data suggest that combination therapies are synergistic in inhibiting viral
replication; these therapies include a foscarnet-ganciclovir combination and a
cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the
combination of intravenous ganciclovir and foscarnet was more effective than either drug
alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent
intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed
disease because it may provide synergy for controlling both ocular and visceral disease while
not necessitating either a central venous catheter or an intraocular surgical procedure.
The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical
trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular
device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be
surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis.
Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be
administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2
weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients
will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per
day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate
that regimen, an alternative systemic regimen will be recommended.
Study outcome variables include a decrease of three or more lines from baseline in best
corrected visual acuity and rate of visual field loss. The study will also assess other
variables including mortality, blood CMV and HIV load, quality of life, and medical costs.
Treatment assignment will not be masked to either patients or clinicians; however, reading of
fundus photographs to determine both change in retinal involvement and progression will be
masked.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 3 years
arm group label: Ganciclovir implant and oral ganciclovir
arm group type: Experimental
description: Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily
arm group label: Cidofovir IV (Intravenous)
arm group type: Experimental
description: cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week
intervention type: Device
intervention name: Ganciclovir implant and oral ganciclovir
description: oral ganciclovir, 1 gm three times daily
arm group label: Ganciclovir implant and oral ganciclovir
other name: Vitraset
intervention type: Drug
intervention name: Cidofovir intravenous
description: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
arm group label: Cidofovir IV (Intravenous)
other name: Vistide
criteria:
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas Jabs, MD
role: Study Chair
affiliation: SOCA Chairman's Office
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
citation: Studies of Ocular Complications of AIDS Research Group. The AIDS Clinical Trials Group.. The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol. 2001 Apr;131(4):457-67. doi: 10.1016/s0002-9394(01)00840-6.
PMID: 11292409
citation: Dunn JP, Van Natta M, Foster G, Kuppermann BD, Martin DF, Zong A, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Complications of ganciclovir implant surgery in patients with cytomegalovirus retinitis: the Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial. Retina. 2004 Feb;24(1):41-50. doi: 10.1097/00006982-200402000-00007.
PMID: 15076943
responsible party type: Sponsor
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate
mesh term: Cidofovir
sharing ipd: Yes
participant flow:
baseline:
outcome list:
reported events:
certain agreements:
point of contact:
|
NCT0000xxxx/NCT00000144.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000144</url>
</required_header>
<id_info>
<org_study_id>NEI-43</org_study_id>
<nct_id>NCT00000144</nct_id>
</id_info>
<brief_title>Glaucoma Laser Trial (GLT) Glaucoma Laser Trial Followup Study (GLTFS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare the safety and long-term efficacy of argon laser treatment of the trabecular
meshwork with standard medical treatment for primary open-angle glaucoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
During the last decade, argon laser trabeculoplasty (ALT) has often been used instead of
surgery as the treatment of choice in cases of open-angle glaucoma that could not be
controlled by drugs. ALT treatment consists of tiny laser burns evenly spaced around the
trabecular meshwork. It sometimes has been found to be effective in controlling glaucoma,
although many eyes still require some medical treatment.

The Glaucoma Laser Trial (GLT), a randomized, controlled clinical trial, was conducted to
determine whether ALT is effective in patients with newly diagnosed, primary, open-angle
glaucoma. Each of the 271 patients in the trial received argon laser treatment in one eye and
standard topical medication in the other eye. The eye to be started on medicine and the eye
that would get the laser treatment were randomly selected. The Glaucoma Laser Trial Followup
Study was a followup study of 203 of the 271 patients who enrolled in the Glaucoma Laser
Trial. By the close of the Glaucoma Laser Trial Followup Study, median duration of followup
since diagnosis of primary, open-angle glaucoma was 7 years (maximum, 9 years).

The argon laser treatment was done in two sessions 1 month apart, with one-half of the
trabecular meshwork treated with 45 to 55 laser burns in each session. Patients were seen for
a followup visit 3 months after the first laser treatment and every 3 months thereafter for a
period of at least 2 years. At each visit, examination of the eyes included a check of
intraocular pressure and visual acuity. Visual field examinations were performed 3, 6, and 12
months after randomization and annually thereafter. Disc stereo photographs were taken 6 and
12 months after randomization and annually thereafter.

The results of these examinations determined whether treatment should be changed. If the
pressure in either eye had not been reduced to the desired level, the physician changed the
medication in the eye treated with drops or started the use of drops in the laser-treated eye
according to a standardized procedure being used in the trial. If intraocular pressure was
still not successfully reduced, surgery or further laser treatment may have been required.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1984</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Open-Angle Glaucoma</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Laser Treatment</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
At the time of recruitment, patients had to be at least 35 years old with an intraocular
pressure of at least 22 mm Hg or greater in each eye and evidence of optic nerve damage in
at least one eye.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>35 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/gltpressrelease.asp</url>
<description>NEI Press Release-Laser Surgery Is Safe And Effective First Treatment For Glaucoma</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/glt-1pressrelease.asp</url>
<description>NEI Press Release-Laser Therapy Show Promise As Alternative to Glaucoma Drugs</description>
</link>
<reference>
<citation>The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.</citation>
<PMID>2255512</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial (GLT): 3. Design and methods. Glaucoma Laser Trial Research Group. Control Clin Trials. 1991 Aug;12(4):504-24. doi: 10.1016/0197-2456(91)90010-j.</citation>
<PMID>1657527</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial: 4. Contralateral effects of timolol on the intraocular pressure of eyes treated with ALT. GLT Research Group. Ophthalmic Surg. 1991 Jun;22(6):324-9.</citation>
<PMID>1896168</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial (GLT): 5. Subgroup differences at enrollment. Glaucoma Laser Trial Research Group. Ophthalmic Surg. 1993 Apr;24(4):232-40.</citation>
<PMID>8321504</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Jul;120(1):10-22. doi: 10.1016/s0002-9394(14)73754-7.</citation>
<PMID>7611312</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial (GLT) and glaucoma laser trial follow-up study: 7. Results. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Dec;120(6):718-31. doi: 10.1016/s0002-9394(14)72725-4.</citation>
<PMID>8540545</PMID>
</reference>
<reference>
<citation>The Glaucoma Laser Trial. I. Acute effects of argon laser trabeculoplasty on intraocular pressure. Glaucoma Laser Trial Research Group. Arch Ophthalmol. 1989 Aug;107(8):1135-42.</citation>
<PMID>2667508</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 2, 2006</last_update_submitted>
<last_update_submitted_qc>June 2, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 5, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Glaucoma, Open-Angle</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000144
org study id: NEI-43
nct id: NCT00000144
lead sponsor:
To compare the safety and long-term efficacy of argon laser treatment of the trabecular
meshwork with standard medical treatment for primary open-angle glaucoma.
During the last decade, argon laser trabeculoplasty (ALT) has often been used instead of
surgery as the treatment of choice in cases of open-angle glaucoma that could not be
controlled by drugs. ALT treatment consists of tiny laser burns evenly spaced around the
trabecular meshwork. It sometimes has been found to be effective in controlling glaucoma,
although many eyes still require some medical treatment.
The Glaucoma Laser Trial (GLT), a randomized, controlled clinical trial, was conducted to
determine whether ALT is effective in patients with newly diagnosed, primary, open-angle
glaucoma. Each of the 271 patients in the trial received argon laser treatment in one eye and
standard topical medication in the other eye. The eye to be started on medicine and the eye
that would get the laser treatment were randomly selected. The Glaucoma Laser Trial Followup
Study was a followup study of 203 of the 271 patients who enrolled in the Glaucoma Laser
Trial. By the close of the Glaucoma Laser Trial Followup Study, median duration of followup
since diagnosis of primary, open-angle glaucoma was 7 years (maximum, 9 years).
The argon laser treatment was done in two sessions 1 month apart, with one-half of the
trabecular meshwork treated with 45 to 55 laser burns in each session. Patients were seen for
a followup visit 3 months after the first laser treatment and every 3 months thereafter for a
period of at least 2 years. At each visit, examination of the eyes included a check of
intraocular pressure and visual acuity. Visual field examinations were performed 3, 6, and 12
months after randomization and annually thereafter. Disc stereo photographs were taken 6 and
12 months after randomization and annually thereafter.
The results of these examinations determined whether treatment should be changed. If the
pressure in either eye had not been reduced to the desired level, the physician changed the
medication in the eye treated with drops or started the use of drops in the laser-treated eye
according to a standardized procedure being used in the trial. If intraocular pressure was
still not successfully reduced, surgery or further laser treatment may have been required.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Argon Laser Treatment
criteria:
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/gltpressrelease.asp
description: NEI Press Release-Laser Surgery Is Safe And Effective First Treatment For Glaucoma
url: http://www.nei.nih.gov/news/pressreleases/glt-1pressrelease.asp
description: NEI Press Release-Laser Therapy Show Promise As Alternative to Glaucoma Drugs
citation: The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology. 1990 Nov;97(11):1403-13.
PMID: 2255512
citation: The Glaucoma Laser Trial (GLT): 3. Design and methods. Glaucoma Laser Trial Research Group. Control Clin Trials. 1991 Aug;12(4):504-24. doi: 10.1016/0197-2456(91)90010-j.
PMID: 1657527
citation: The Glaucoma Laser Trial: 4. Contralateral effects of timolol on the intraocular pressure of eyes treated with ALT. GLT Research Group. Ophthalmic Surg. 1991 Jun;22(6):324-9.
PMID: 1896168
citation: The Glaucoma Laser Trial (GLT): 5. Subgroup differences at enrollment. Glaucoma Laser Trial Research Group. Ophthalmic Surg. 1993 Apr;24(4):232-40.
PMID: 8321504
citation: The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Jul;120(1):10-22. doi: 10.1016/s0002-9394(14)73754-7.
PMID: 7611312
citation: The Glaucoma Laser Trial (GLT) and glaucoma laser trial follow-up study: 7. Results. Glaucoma Laser Trial Research Group. Am J Ophthalmol. 1995 Dec;120(6):718-31. doi: 10.1016/s0002-9394(14)72725-4.
PMID: 8540545
citation: The Glaucoma Laser Trial. I. Acute effects of argon laser trabeculoplasty on intraocular pressure. Glaucoma Laser Trial Research Group. Arch Ophthalmol. 1989 Aug;107(8):1135-42.
PMID: 2667508
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
|
NCT0000xxxx/NCT00000145.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000145</url>
</required_header>
<id_info>
<org_study_id>NEI-44</org_study_id>
<nct_id>NCT00000145</nct_id>
<nct_alias>NCT00001312</nct_alias>
</id_info>
<brief_title>Age-Related Eye Disease Study (AREDS)</brief_title>
<official_title>Age-Related Eye Disease Study (AREDS)</official_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Bausch & Lomb Incorporated</agency>
<agency_class>Industry</agency_class>
</collaborator>
</sponsors>
<source>National Eye Institute (NEI)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To assess the clinical course, prognosis, and risk factors of age-related macular
degeneration (AMD) and cataract.

To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1)
antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and
progression of lens opacities.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
AMD and cataract are the leading causes of visual impairment and blindness in the United
States. Based on many clinical studies, it is apparent that the frequency of both diseases
increases dramatically after age 60. Although excellent treatments for cataract are
available, there are no equivalent treatments for AMD. As the average lifespan of our
population increases, the number of people who develop AMD will increase dramatically in the
years ahead. Unless successful means of prevention or treatment are developed, blindness from
AMD -- and its importance as a public health problem -- will increase.

Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic
studies suggest that a number of risk factors may be associated with AMD and cataract, but
the strength of the evidence in support of these hypotheses varies. Possibly associated with
AMD are personal characteristics, such as age, race, height, family history, and strength of
hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular
diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies
suggest the following factors may be associated with progression of AMD: drusen type,
choroidal vascular diseases, and photic injury.

Epidemiologic studies of cataract suggest that associated risk factors may include personal
characteristics, such as age, sex, race, occupation, and educational status; ocular
characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure,
smoking, and sunlight exposure. Animal studies and observational epidemiologic studies
suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and
selenium also may be associated with the development of the two diseases, especially
cataract. Although surgical treatment to remove cataract is very effective, cataract surgery
carries risks, as does any other surgery. Therefore, many research efforts focus on
preventing or slowing cataract development, as well as on determining the causes of cataract
formation.

The Age-Related Eye Disease Study (AREDS) is a major research program to improve our
understanding of the predisposing factors, clinical course, and prognostic factors of AMD and
cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or
antioxidants plus zinc, and are followed for a minimum of 5 years.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>September 1990</start_date>
<completion_date type="Actual">December 2006</completion_date>
<primary_completion_date type="Actual">October 2001</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Progression of age-related macular degeneration</measure>
</primary_outcome>
<primary_outcome>
<measure>Progression of lens opacity (cataract)</measure>
</primary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Actual">4757</enrollment>
<condition>Macular Degeneration</condition>
<condition>Cataract</condition>
<condition>Lens Opacities</condition>
<arm_group>
<arm_group_label>1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Antioxidants</description>
</arm_group>
<arm_group>
<arm_group_label>2</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Zinc</description>
</arm_group>
<arm_group>
<arm_group_label>3</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Antioxidants and zinc</description>
</arm_group>
<arm_group>
<arm_group_label>4</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
</arm_group>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Antioxidants</intervention_name>
<description>500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene</description>
<arm_group_label>1</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Zinc</intervention_name>
<description>80 milligrams zinc oxide; 2 milligrams of cupric oxide</description>
<arm_group_label>2</arm_group_label>
</intervention>
<intervention>
<intervention_type>Dietary Supplement</intervention_type>
<intervention_name>Antioxidants and zinc</intervention_name>
<description>500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide</description>
<arm_group_label>3</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women between the ages of 55 and 80 years whose macular status ranges from no
evidence of AMD in either eye to relatively severe disease with vision loss in one eye but
good vision in the fellow eye (20/30 or better) are eligible for the study provided that
their ocular media are clear enough to allow good fundus photography.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Emily Y. Chew, MD</last_name>
<role>Principal Investigator</role>
<affiliation>National Eye Institute (NEI)</affiliation>
</overall_official>
<reference>
<citation>Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study system for classifying age-related macular degeneration from stereoscopic color fundus photographs: the Age-Related Eye Disease Study Report Number 6. Am J Ophthalmol. 2001 Nov;132(5):668-81. doi: 10.1016/s0002-9394(01)01218-1.</citation>
<PMID>11704028</PMID>
</reference>
<reference>
<citation>Age-Related Eye Disease Study Research Group. The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report no. 4. Am J Ophthalmol. 2001 Feb;131(2):167-75. doi: 10.1016/s0002-9394(00)00732-7.</citation>
<PMID>11228291</PMID>
</reference>
<reference>
<citation>Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): design implications. AREDS report no. 1. Control Clin Trials. 1999 Dec;20(6):573-600. doi: 10.1016/s0197-2456(99)00031-8.</citation>
<PMID>10588299</PMID>
</reference>
<reference>
<citation>Clemons TE, Chew EY, Bressler SB, McBee W; Age-Related Eye Disease Study Research Group. National Eye Institute Visual Function Questionnaire in the Age-Related Eye Disease Study (AREDS): AREDS Report No. 10. Arch Ophthalmol. 2003 Feb;121(2):211-7. doi: 10.1001/archopht.121.2.211.</citation>
<PMID>12583787</PMID>
</reference>
<reference>
<citation>Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.</citation>
<PMID>14609922</PMID>
</reference>
<reference>
<citation>Lindblad AS, Clemons TE. Responsiveness of the National Eye Institute Visual Function Questionnaire to progression to advanced age-related macular degeneration, vision loss, and lens opacity: AREDS Report no. 14. Arch Ophthalmol. 2005 Sep;123(9):1207-14. doi: 10.1001/archopht.123.9.1207.</citation>
<PMID>16157800</PMID>
</reference>
<reference>
<citation>Rankin MW, Clemons TE, McBee WL. Correlation analysis of the in-clinic and telephone batteries from the AREDS cognitive function ancillary study. AREDS Report No. 15. Ophthalmic Epidemiol. 2005 Aug;12(4):271-7. doi: 10.1080/09286580591003815.</citation>
<PMID>16033748</PMID>
</reference>
<reference>
<citation>Davis MD, Gangnon RE, Lee LY, Hubbard LD, Klein BE, Klein R, Ferris FL, Bressler SB, Milton RC; Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005 Nov;123(11):1484-98. doi: 10.1001/archopht.123.11.1484. Erratum In: Arch Ophthalmol. 2006 Feb;124(2):289-90.</citation>
<PMID>16286610</PMID>
</reference>
<reference>
<citation>Ferris FL, Davis MD, Clemons TE, Lee LY, Chew EY, Lindblad AS, Milton RC, Bressler SB, Klein R; Age-Related Eye Disease Study (AREDS) Research Group. A simplified severity scale for age-related macular degeneration: AREDS Report No. 18. Arch Ophthalmol. 2005 Nov;123(11):1570-4. doi: 10.1001/archopht.123.11.1570.</citation>
<PMID>16286620</PMID>
</reference>
<reference>
<citation>Sperduto RD, Ferris FL 3rd, Kurinij N. Do we have a nutritional treatment for age-related cataract or macular degeneration? Arch Ophthalmol. 1990 Oct;108(10):1403-5. doi: 10.1001/archopht.1990.01070120051026. No abstract available.</citation>
<PMID>2222272</PMID>
</reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. The effect of five-year zinc supplementation on serum zinc, serum cholesterol and hematocrit in persons randomly assigned to treatment group in the age-related eye disease study: AREDS Report No. 7. J Nutr. 2002 Apr;132(4):697-702. doi: 10.1093/jn/132.4.697.</citation>
<PMID>11925463</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. Risk factors associated with age-related nuclear and cortical cataract : a case-control study in the Age-Related Eye Disease Study, AREDS Report No. 5. Ophthalmology. 2001 Aug;108(8):1400-8. doi: 10.1016/s0161-6420(01)00626-1.</citation>
<PMID>11470690</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. Risk factors associated with age-related macular degeneration. A case-control study in the age-related eye disease study: Age-Related Eye Disease Study Report Number 3. Ophthalmology. 2000 Dec;107(12):2224-32. doi: 10.1016/s0161-6420(00)00409-7.</citation>
<PMID>11097601</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study: a clinical trial of zinc and antioxidants--Age-Related Eye Disease Study Report No. 2. J Nutr. 2000 May;130(5S Suppl):1516S-9S. doi: 10.1093/jn/130.5.1516S.</citation>
<PMID>10801969</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9. Arch Ophthalmol. 2001 Oct;119(10):1439-52. doi: 10.1001/archopht.119.10.1439. Erratum In: Arch Ophthalmol. 2008 Sep;126(9):1251.</citation>
<PMID>11594943</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417. Erratum In: Arch Ophthalmol. 2008 Sep;126(9):1251.</citation>
<PMID>11594942</PMID>
</results_reference>
<results_reference>
<citation>Yaffe K, Clemons TE, McBee WL, Lindblad AS; Age-Related Eye Disease Study Research Group. Impact of antioxidants, zinc, and copper on cognition in the elderly: a randomized, controlled trial. Neurology. 2004 Nov 9;63(9):1705-7. doi: 10.1212/01.wnl.0000142969.19465.8f.</citation>
<PMID>15534261</PMID>
</results_reference>
<results_reference>
<citation>Clemons TE, Kurinij N, Sperduto RD; AREDS Research Group. Associations of mortality with ocular disorders and an intervention of high-dose antioxidants and zinc in the Age-Related Eye Disease Study: AREDS Report No. 13. Arch Ophthalmol. 2004 May;122(5):716-26. doi: 10.1001/archopht.122.5.716.</citation>
<PMID>15136320</PMID>
</results_reference>
<results_reference>
<citation>Clemons TE, Rankin MW, McBee WL; Age-Related Eye Disease Study Research Group. Cognitive impairment in the Age-Related Eye Disease Study: AREDS report no. 16. Arch Ophthalmol. 2006 Apr;124(4):537-43. doi: 10.1001/archopht.124.4.537.</citation>
<PMID>16606880</PMID>
</results_reference>
<results_reference>
<citation>Clemons TE, Milton RC, Klein R, Seddon JM, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Risk factors for the incidence of Advanced Age-Related Macular Degeneration in the Age-Related Eye Disease Study (AREDS) AREDS report no. 19. Ophthalmology. 2005 Apr;112(4):533-9. doi: 10.1016/j.ophtha.2004.10.047.</citation>
<PMID>15808240</PMID>
</results_reference>
<results_reference>
<citation>SanGiovanni JP, Chew EY, Clemons TE, Davis MD, Ferris FL 3rd, Gensler GR, Kurinij N, Lindblad AS, Milton RC, Seddon JM, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary lipid intake and age-related macular degeneration in a case-control study: AREDS Report No. 20. Arch Ophthalmol. 2007 May;125(5):671-9. doi: 10.1001/archopht.125.5.671.</citation>
<PMID>17502507</PMID>
</results_reference>
<results_reference>
<citation>Milton RC, Sperduto RD, Clemons TE, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Centrum use and progression of age-related cataract in the Age-Related Eye Disease Study: a propensity score approach. AREDS report No. 21. Ophthalmology. 2006 Aug;113(8):1264-70. doi: 10.1016/j.ophtha.2006.02.054.</citation>
<PMID>16877067</PMID>
</results_reference>
<results_reference>
<citation>Age-Related Eye Disease Study Research Group; SanGiovanni JP, Chew EY, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Sperduto RD. The relationship of dietary carotenoid and vitamin A, E, and C intake with age-related macular degeneration in a case-control study: AREDS Report No. 22. Arch Ophthalmol. 2007 Sep;125(9):1225-32. doi: 10.1001/archopht.125.9.1225.</citation>
<PMID>17846363</PMID>
</results_reference>
<results_reference>
<citation>SanGiovanni JP, Chew EY, Agron E, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Klein R, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary omega-3 long-chain polyunsaturated fatty acid intake with incident age-related macular degeneration: AREDS report no. 23. Arch Ophthalmol. 2008 Sep;126(9):1274-9. doi: 10.1001/archopht.126.9.1274.</citation>
<PMID>18779490</PMID>
</results_reference>
<results_reference>
<citation>Sperduto RD, Clemons TE, Lindblad AS, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Cataract classification using serial examinations in the age-related eye disease study: age-related eye disease study report no. 24. Am J Ophthalmol. 2008 Mar;145(3):504-8. doi: 10.1016/j.ajo.2007.10.024. Epub 2008 Jan 16.</citation>
<PMID>18201681</PMID>
</results_reference>
<verification_date>January 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>January 21, 2009</last_update_submitted>
<last_update_submitted_qc>January 21, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">January 23, 2009</last_update_posted>
<responsible_party>
<name_title>John Paul SanGiovanni, Sc.D.</name_title>
<organization>National Eye Institute</organization>
</responsible_party>
<keyword>Age-Related Macular Degeneration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Degeneration</mesh_term>
<mesh_term>Cataract</mesh_term>
<mesh_term>Eye Diseases</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Zinc</mesh_term>
<mesh_term>Antioxidants</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000145
org study id: NEI-44
nct id: NCT00000145
nct alias: NCT00001312
lead sponsor:
collaborator:
has dmc: Yes
To assess the clinical course, prognosis, and risk factors of age-related macular
degeneration (AMD) and cataract.
To evaluate, in randomized clinical trials, the effects of pharmacologic doses of (1)
antioxidants and zinc on the progression of AMD and (2) antioxidants on the development and
progression of lens opacities.
AMD and cataract are the leading causes of visual impairment and blindness in the United
States. Based on many clinical studies, it is apparent that the frequency of both diseases
increases dramatically after age 60. Although excellent treatments for cataract are
available, there are no equivalent treatments for AMD. As the average lifespan of our
population increases, the number of people who develop AMD will increase dramatically in the
years ahead. Unless successful means of prevention or treatment are developed, blindness from
AMD -- and its importance as a public health problem -- will increase.
Neither the etiology nor the natural history of AMD or cataract is known. Epidemiologic
studies suggest that a number of risk factors may be associated with AMD and cataract, but
the strength of the evidence in support of these hypotheses varies. Possibly associated with
AMD are personal characteristics, such as age, race, height, family history, and strength of
hand grip; ocular characteristics, such as hyperopia and color of iris; and cardiovascular
diseases, smoking, lung infections, and chemical exposures. Clinical and laboratory studies
suggest the following factors may be associated with progression of AMD: drusen type,
choroidal vascular diseases, and photic injury.
Epidemiologic studies of cataract suggest that associated risk factors may include personal
characteristics, such as age, sex, race, occupation, and educational status; ocular
characteristics, such as iris color; and diabetes mellitus, hypertension, drug exposure,
smoking, and sunlight exposure. Animal studies and observational epidemiologic studies
suggest that deficiencies in vitamins C and E, carotenoids, and the trace elements zinc and
selenium also may be associated with the development of the two diseases, especially
cataract. Although surgical treatment to remove cataract is very effective, cataract surgery
carries risks, as does any other surgery. Therefore, many research efforts focus on
preventing or slowing cataract development, as well as on determining the causes of cataract
formation.
The Age-Related Eye Disease Study (AREDS) is a major research program to improve our
understanding of the predisposing factors, clinical course, and prognostic factors of AMD and
cataract. Eligible patients are randomized to treatment with placebo, antioxidants, zinc, or
antioxidants plus zinc, and are followed for a minimum of 5 years.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression of age-related macular degeneration
measure: Progression of lens opacity (cataract)
arm group label: 1
arm group type: Experimental
description: Antioxidants
arm group label: 2
arm group type: Experimental
description: Zinc
arm group label: 3
arm group type: Experimental
description: Antioxidants and zinc
arm group label: 4
arm group type: No Intervention
intervention type: Dietary Supplement
intervention name: Antioxidants
description: 500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene
arm group label: 1
intervention type: Dietary Supplement
intervention name: Zinc
description: 80 milligrams zinc oxide; 2 milligrams of cupric oxide
arm group label: 2
intervention type: Dietary Supplement
intervention name: Antioxidants and zinc
description: 500 milligrams vitamin C; 400 IUs vitamin E; 15 milligrams beta-carotene; 80 milligrams zinc oxide; 2 milligrams of cupric oxide
arm group label: 3
criteria:
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Emily Y. Chew, MD
role: Principal Investigator
affiliation: National Eye Institute (NEI)
citation: Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study system for classifying age-related macular degeneration from stereoscopic color fundus photographs: the Age-Related Eye Disease Study Report Number 6. Am J Ophthalmol. 2001 Nov;132(5):668-81. doi: 10.1016/s0002-9394(01)01218-1.
PMID: 11704028
citation: Age-Related Eye Disease Study Research Group. The age-related eye disease study (AREDS) system for classifying cataracts from photographs: AREDS report no. 4. Am J Ophthalmol. 2001 Feb;131(2):167-75. doi: 10.1016/s0002-9394(00)00732-7.
PMID: 11228291
citation: Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): design implications. AREDS report no. 1. Control Clin Trials. 1999 Dec;20(6):573-600. doi: 10.1016/s0197-2456(99)00031-8.
PMID: 10588299
citation: Clemons TE, Chew EY, Bressler SB, McBee W; Age-Related Eye Disease Study Research Group. National Eye Institute Visual Function Questionnaire in the Age-Related Eye Disease Study (AREDS): AREDS Report No. 10. Arch Ophthalmol. 2003 Feb;121(2):211-7. doi: 10.1001/archopht.121.2.211.
PMID: 12583787
citation: Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.
PMID: 14609922
citation: Lindblad AS, Clemons TE. Responsiveness of the National Eye Institute Visual Function Questionnaire to progression to advanced age-related macular degeneration, vision loss, and lens opacity: AREDS Report no. 14. Arch Ophthalmol. 2005 Sep;123(9):1207-14. doi: 10.1001/archopht.123.9.1207.
PMID: 16157800
citation: Rankin MW, Clemons TE, McBee WL. Correlation analysis of the in-clinic and telephone batteries from the AREDS cognitive function ancillary study. AREDS Report No. 15. Ophthalmic Epidemiol. 2005 Aug;12(4):271-7. doi: 10.1080/09286580591003815.
PMID: 16033748
citation: Davis MD, Gangnon RE, Lee LY, Hubbard LD, Klein BE, Klein R, Ferris FL, Bressler SB, Milton RC; Age-Related Eye Disease Study Group. The Age-Related Eye Disease Study severity scale for age-related macular degeneration: AREDS Report No. 17. Arch Ophthalmol. 2005 Nov;123(11):1484-98. doi: 10.1001/archopht.123.11.1484. Erratum In: Arch Ophthalmol. 2006 Feb;124(2):289-90.
PMID: 16286610
citation: Ferris FL, Davis MD, Clemons TE, Lee LY, Chew EY, Lindblad AS, Milton RC, Bressler SB, Klein R; Age-Related Eye Disease Study (AREDS) Research Group. A simplified severity scale for age-related macular degeneration: AREDS Report No. 18. Arch Ophthalmol. 2005 Nov;123(11):1570-4. doi: 10.1001/archopht.123.11.1570.
PMID: 16286620
citation: Sperduto RD, Ferris FL 3rd, Kurinij N. Do we have a nutritional treatment for age-related cataract or macular degeneration? Arch Ophthalmol. 1990 Oct;108(10):1403-5. doi: 10.1001/archopht.1990.01070120051026. No abstract available.
PMID: 2222272
citation: Age-Related Eye Disease Study Research Group. The effect of five-year zinc supplementation on serum zinc, serum cholesterol and hematocrit in persons randomly assigned to treatment group in the age-related eye disease study: AREDS Report No. 7. J Nutr. 2002 Apr;132(4):697-702. doi: 10.1093/jn/132.4.697.
PMID: 11925463
citation: Age-Related Eye Disease Study Research Group. Risk factors associated with age-related nuclear and cortical cataract : a case-control study in the Age-Related Eye Disease Study, AREDS Report No. 5. Ophthalmology. 2001 Aug;108(8):1400-8. doi: 10.1016/s0161-6420(01)00626-1.
PMID: 11470690
citation: Age-Related Eye Disease Study Research Group. Risk factors associated with age-related macular degeneration. A case-control study in the age-related eye disease study: Age-Related Eye Disease Study Report Number 3. Ophthalmology. 2000 Dec;107(12):2224-32. doi: 10.1016/s0161-6420(00)00409-7.
PMID: 11097601
citation: Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study: a clinical trial of zinc and antioxidants--Age-Related Eye Disease Study Report No. 2. J Nutr. 2000 May;130(5S Suppl):1516S-9S. doi: 10.1093/jn/130.5.1516S.
PMID: 10801969
citation: Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS report no. 9. Arch Ophthalmol. 2001 Oct;119(10):1439-52. doi: 10.1001/archopht.119.10.1439. Erratum In: Arch Ophthalmol. 2008 Sep;126(9):1251.
PMID: 11594943
citation: Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. doi: 10.1001/archopht.119.10.1417. Erratum In: Arch Ophthalmol. 2008 Sep;126(9):1251.
PMID: 11594942
citation: Yaffe K, Clemons TE, McBee WL, Lindblad AS; Age-Related Eye Disease Study Research Group. Impact of antioxidants, zinc, and copper on cognition in the elderly: a randomized, controlled trial. Neurology. 2004 Nov 9;63(9):1705-7. doi: 10.1212/01.wnl.0000142969.19465.8f.
PMID: 15534261
citation: Clemons TE, Kurinij N, Sperduto RD; AREDS Research Group. Associations of mortality with ocular disorders and an intervention of high-dose antioxidants and zinc in the Age-Related Eye Disease Study: AREDS Report No. 13. Arch Ophthalmol. 2004 May;122(5):716-26. doi: 10.1001/archopht.122.5.716.
PMID: 15136320
citation: Clemons TE, Rankin MW, McBee WL; Age-Related Eye Disease Study Research Group. Cognitive impairment in the Age-Related Eye Disease Study: AREDS report no. 16. Arch Ophthalmol. 2006 Apr;124(4):537-43. doi: 10.1001/archopht.124.4.537.
PMID: 16606880
citation: Clemons TE, Milton RC, Klein R, Seddon JM, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Risk factors for the incidence of Advanced Age-Related Macular Degeneration in the Age-Related Eye Disease Study (AREDS) AREDS report no. 19. Ophthalmology. 2005 Apr;112(4):533-9. doi: 10.1016/j.ophtha.2004.10.047.
PMID: 15808240
citation: SanGiovanni JP, Chew EY, Clemons TE, Davis MD, Ferris FL 3rd, Gensler GR, Kurinij N, Lindblad AS, Milton RC, Seddon JM, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary lipid intake and age-related macular degeneration in a case-control study: AREDS Report No. 20. Arch Ophthalmol. 2007 May;125(5):671-9. doi: 10.1001/archopht.125.5.671.
PMID: 17502507
citation: Milton RC, Sperduto RD, Clemons TE, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Centrum use and progression of age-related cataract in the Age-Related Eye Disease Study: a propensity score approach. AREDS report No. 21. Ophthalmology. 2006 Aug;113(8):1264-70. doi: 10.1016/j.ophtha.2006.02.054.
PMID: 16877067
citation: Age-Related Eye Disease Study Research Group; SanGiovanni JP, Chew EY, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Sperduto RD. The relationship of dietary carotenoid and vitamin A, E, and C intake with age-related macular degeneration in a case-control study: AREDS Report No. 22. Arch Ophthalmol. 2007 Sep;125(9):1225-32. doi: 10.1001/archopht.125.9.1225.
PMID: 17846363
citation: SanGiovanni JP, Chew EY, Agron E, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Klein R, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary omega-3 long-chain polyunsaturated fatty acid intake with incident age-related macular degeneration: AREDS report no. 23. Arch Ophthalmol. 2008 Sep;126(9):1274-9. doi: 10.1001/archopht.126.9.1274.
PMID: 18779490
citation: Sperduto RD, Clemons TE, Lindblad AS, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Cataract classification using serial examinations in the age-related eye disease study: age-related eye disease study report no. 24. Am J Ophthalmol. 2008 Mar;145(3):504-8. doi: 10.1016/j.ajo.2007.10.024. Epub 2008 Jan 16.
PMID: 18201681
name title: John Paul SanGiovanni, Sc.D.
organization: National Eye Institute
mesh term: Macular Degeneration
mesh term: Cataract
mesh term: Eye Diseases
mesh term: Zinc
mesh term: Antioxidants
|
NCT0000xxxx/NCT00000146.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000146</url>
</required_header>
<id_info>
<org_study_id>NEI-47</org_study_id>
<nct_id>NCT00000146</nct_id>
</id_info>
<brief_title>Optic Neuritis Treatment Trial (ONTT)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.

To determine the natural history of vision in patients who suffer optic neuritis.

To identify risk factors for the development of multiple sclerosis in patients with optic
neuritis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Optic neuritis is an inflammatory disease of the optic nerve that typically affects young
adults. Women are affected more often than men. It is second only to glaucoma as the most
common acquired optic nerve disorder in persons younger than age 50.

In this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is
generally good. However, return of visual function is almost never complete. After resolution
of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are
symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain
in other measures such as contrast sensitivity, color vision, and visual field.

Prior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating
optic neuritis did not exist. Although corticosteroids had been used to treat this disease,
studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated
treatment with oral prednisone while others recommended no treatment. Anecdotal reports
suggested that high-dose intravenous corticosteroids might be effective.

The association between optic neuritis and multiple sclerosis is well established. Optic
neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its
course. A strong case can be made for "isolated" optic neuritis being a forme fruste of
multiple sclerosis, based on similarities between the two in such epidemiologic factors as
gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data,
magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of
multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very
disparate results, with the risk being reported to be as low as 13 percent and as high as 88
percent. The importance of risk factors such as age, gender, and MRI changes in predicting
which patients with optic neuritis are most likely to develop multiple sclerosis also is
unclear.

The treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT),
whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study
(LONS). The study is being conducted at 15 clinical centers in the United States. Resource
centers include a data coordinating center and a visual field reading center.

Patients were randomized to one of the three following treatment groups at 15 clinical
centers:

- Oral prednisone (1 mg/kg/day) for 14 days

- Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral
prednisone (1 mg/kg/day) for 11 days

- Oral placebo for 14 days

Each regimen was followed by a short oral taper. The oral prednisone and placebo groups were
double masked, whereas the intravenous methylprednisolone group was single masked.

Baseline testing included blood tests to evaluate for syphilis and systemic lupus
erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate
for changes suggestive of multiple sclerosis.

The rate of visual recovery and the long-term visual outcome were both assessed by measures
of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven
followup visits during the first 6 months, and then yearly. A standardized neurologic
examination with an assessment of multiple sclerosis status was made at baseline, after 6
months, and then yearly.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>July 1988</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Single</masking>
</study_design_info>
<condition>Multiple Sclerosis</condition>
<condition>Optic Neuritis</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Methylprednisolone</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Prednisone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The major eligibility criteria for enrollment into the ONTT included the following:

Age range of 18 to 46 years

Acute unilateral optic neuritis with visual symptoms for 8 days or less

A relative afferent pupillary defect and a visual field defect in the affected eye

No previous episodes of optic neuritis in the affected eye

No previous corticosteroid treatment for optic neuritis or multiple sclerosis

No systemic disease other than multiple sclerosis that might be the cause of the optic
neuritis
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>46 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Arkansas</name>
<address>
<city>Little Rock</city>
<state>Arkansas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>California Pacific Medical Center</name>
<address>
<city>San Francisco</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Georgetown University</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Florida</name>
<address>
<city>Gainesville</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Illinois</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Iowa</name>
<address>
<city>Iowa City</city>
<state>Iowa</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Michigan State University</name>
<address>
<city>East Lansing</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University</name>
<address>
<city>New York</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Devers Eye Institute</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wills Eye Hospital</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Swedish Medical Center</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-ontt.asp</url>
<description>Clinical Alert to Ophthalmologists and Neurologists who Treat Patients with Optic Neuritis</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/onttpressrelease.asp</url>
<description>NEI Press Release-Corticosteroids for First-Time Optic Neuritis Lowers Risk of Developing Multiple Sclerosis</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/ontt-1pressrelease.asp</url>
<description>NEI Press Release-Oral Corticosteroids Alone Found Ineffective for Optic Neuritis</description>
</link>
<reference>
<citation>Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6.</citation>
<PMID>8500302</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7.</citation>
<PMID>8500303</PMID>
</reference>
<reference>
<citation>Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9.</citation>
<PMID>8932973</PMID>
</reference>
<reference>
<citation>Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)</citation>
</reference>
<reference>
<citation>Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52.</citation>
<PMID>9400788</PMID>
</reference>
<reference>
<citation>The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.</citation>
<PMID>1841573</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.</citation>
<PMID>1734247</PMID>
</reference>
<reference>
<citation>Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available.</citation>
<PMID>1318520</PMID>
</reference>
<reference>
<citation>Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available.</citation>
<PMID>1543448</PMID>
</reference>
<reference>
<citation>Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013.</citation>
<PMID>8352671</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023.</citation>
<PMID>8512477</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available.</citation>
<PMID>8447730</PMID>
</reference>
<reference>
<citation>Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210</citation>
</reference>
<reference>
<citation>Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9.</citation>
<PMID>8493012</PMID>
</reference>
<reference>
<citation>Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2.</citation>
<PMID>8468765</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029.</citation>
<PMID>8431161</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1.</citation>
<PMID>7800355</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027.</citation>
<PMID>8031275</PMID>
</reference>
<reference>
<citation>Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available.</citation>
<PMID>7864737</PMID>
</reference>
<reference>
<citation>Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available.</citation>
<PMID>8574355</PMID>
</reference>
<reference>
<citation>Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available.</citation>
<PMID>9097798</PMID>
</reference>
<reference>
<citation>Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368.</citation>
<PMID>8614496</PMID>
</reference>
<reference>
<citation>Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7.</citation>
<PMID>8610798</PMID>
</reference>
<reference>
<citation>Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1.</citation>
<PMID>9093956</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 2, 2006</last_update_submitted>
<last_update_submitted_qc>June 2, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 5, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Sclerosis</mesh_term>
<mesh_term>Neuritis</mesh_term>
<mesh_term>Optic Neuritis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Prednisone</mesh_term>
<mesh_term>Methylprednisolone</mesh_term>
<mesh_term>Methylprednisolone Acetate</mesh_term>
<mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
<mesh_term>Prednisolone</mesh_term>
<mesh_term>Prednisolone acetate</mesh_term>
<mesh_term>Prednisolone hemisuccinate</mesh_term>
<mesh_term>Prednisolone phosphate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000146
org study id: NEI-47
nct id: NCT00000146
lead sponsor:
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.
To determine the natural history of vision in patients who suffer optic neuritis.
To identify risk factors for the development of multiple sclerosis in patients with optic
neuritis.
Optic neuritis is an inflammatory disease of the optic nerve that typically affects young
adults. Women are affected more often than men. It is second only to glaucoma as the most
common acquired optic nerve disorder in persons younger than age 50.
In this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is
generally good. However, return of visual function is almost never complete. After resolution
of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are
symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain
in other measures such as contrast sensitivity, color vision, and visual field.
Prior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating
optic neuritis did not exist. Although corticosteroids had been used to treat this disease,
studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated
treatment with oral prednisone while others recommended no treatment. Anecdotal reports
suggested that high-dose intravenous corticosteroids might be effective.
The association between optic neuritis and multiple sclerosis is well established. Optic
neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its
course. A strong case can be made for "isolated" optic neuritis being a forme fruste of
multiple sclerosis, based on similarities between the two in such epidemiologic factors as
gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data,
magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of
multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very
disparate results, with the risk being reported to be as low as 13 percent and as high as 88
percent. The importance of risk factors such as age, gender, and MRI changes in predicting
which patients with optic neuritis are most likely to develop multiple sclerosis also is
unclear.
The treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT),
whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study
(LONS). The study is being conducted at 15 clinical centers in the United States. Resource
centers include a data coordinating center and a visual field reading center.
Patients were randomized to one of the three following treatment groups at 15 clinical
centers:
- Oral prednisone (1 mg/kg/day) for 14 days
- Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral
prednisone (1 mg/kg/day) for 11 days
- Oral placebo for 14 days
Each regimen was followed by a short oral taper. The oral prednisone and placebo groups were
double masked, whereas the intravenous methylprednisolone group was single masked.
Baseline testing included blood tests to evaluate for syphilis and systemic lupus
erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate
for changes suggestive of multiple sclerosis.
The rate of visual recovery and the long-term visual outcome were both assessed by measures
of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven
followup visits during the first 6 months, and then yearly. A standardized neurologic
examination with an assessment of multiple sclerosis status was made at baseline, after 6
months, and then yearly.
allocation: Randomized
primary purpose: Treatment
masking: Single
intervention type: Drug
intervention name: Methylprednisolone
intervention type: Drug
intervention name: Prednisone
criteria:
gender: All
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/news/clinicalalerts/alert-ontt.asp
description: Clinical Alert to Ophthalmologists and Neurologists who Treat Patients with Optic Neuritis
url: http://www.nei.nih.gov/news/pressreleases/onttpressrelease.asp
description: NEI Press Release-Corticosteroids for First-Time Optic Neuritis Lowers Risk of Developing Multiple Sclerosis
url: http://www.nei.nih.gov/news/pressreleases/ontt-1pressrelease.asp
description: NEI Press Release-Oral Corticosteroids Alone Found Ineffective for Optic Neuritis
citation: Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6.
PMID: 8500302
citation: Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7.
PMID: 8500303
citation: Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9.
PMID: 8932973
citation: Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)
citation: Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52.
PMID: 9400788
citation: The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.
PMID: 1841573
citation: Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.
PMID: 1734247
citation: Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available.
PMID: 1318520
citation: Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available.
PMID: 1543448
citation: Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013.
PMID: 8352671
citation: Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023.
PMID: 8512477
citation: Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available.
PMID: 8447730
citation: Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210
citation: Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9.
PMID: 8493012
citation: Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2.
PMID: 8468765
citation: Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029.
PMID: 8431161
citation: Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1.
PMID: 7800355
citation: Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027.
PMID: 8031275
citation: Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available.
PMID: 7864737
citation: Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available.
PMID: 8574355
citation: Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available.
PMID: 9097798
citation: Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368.
PMID: 8614496
citation: Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7.
PMID: 8610798
citation: Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1.
PMID: 9093956
mesh term: Multiple Sclerosis
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Prednisone
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
|
NCT0000xxxx/NCT00000147.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000147</url>
</required_header>
<id_info>
<org_study_id>NEI-48</org_study_id>
<nct_id>NCT00000147</nct_id>
</id_info>
<brief_title>Longitudinal Optic Neuritis Study (LONS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.

To determine the natural history of vision in patients who suffer optic neuritis.

To identify risk factors for the development of multiple sclerosis in patients with optic
neuritis.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Optic neuritis is an inflammatory disease of the optic nerve that typically affects young
adults. Women are affected more often than men. It is second only to glaucoma as the most
common acquired optic nerve disorder in persons younger than age 50.

In this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is
generally good. However, return of visual function is almost never complete. After resolution
of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are
symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain
in other measures such as contrast sensitivity, color vision, and visual field.

Prior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating
optic neuritis did not exist. Although corticosteroids had been used to treat this disease,
studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated
treatment with oral prednisone while others recommended no treatment. Anecdotal reports
suggested that high-dose intravenous corticosteroids might be effective.

The association between optic neuritis and multiple sclerosis is well established. Optic
neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its
course. A strong case can be made for "isolated" optic neuritis being a forme fruste of
multiple sclerosis, based on similarities between the two in such epidemiologic factors as
gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data,
magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of
multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very
disparate results, with the risk being reported to be as low as 13 percent and as high as 88
percent. The importance of risk factors such as age, gender, and MRI changes in predicting
which patients with optic neuritis are most likely to develop multiple sclerosis also is
unclear.

The treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT),
whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study
(LONS). The study is being conducted at 15 clinical centers in the United States. Resource
centers include a data coordinating center and a visual field reading center.

Patients were randomized to one of the three following treatment groups at 15 clinical
centers:

- Oral prednisone (1 mg/kg/day) for 14 days

- Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral
prednisone (1 mg/kg/day) for 11 days

- Oral placebo for 14 days.

Each regimen was followed by a short oral taper. The oral prednisone and placebo groups were
double masked, whereas the intravenous methylprednisolone group was single masked.

Baseline testing included blood tests to evaluate for syphilis and systemic lupus
erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate
for changes suggestive of multiple sclerosis.

The rate of visual recovery and the long-term visual outcome were both assessed by measures
of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven
followup visits during the first 6 months, and then yearly. A standardized neurologic
examination with an assessment of multiple sclerosis status was made at baseline, after 6
months, and then yearly.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>July 1988</start_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Single</masking>
</study_design_info>
<condition>Multiple Sclerosis</condition>
<condition>Optic Neuritis</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Methylprednisolone</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Prednisone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The major eligibility criteria for enrollment into the ONTT included the following:

Age range of 18 to 46 years

Acute unilateral optic neuritis with visual symptoms for 8 days or less

A relative afferent pupillary defect and a visual field defect in the affected eye

No previous episodes of optic neuritis in the affected eye

No previous corticosteroid treatment for optic neuritis or multiple sclerosis

No systemic disease other than multiple sclerosis that might be the cause of the optic
neuritis
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>46 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Arkansas</name>
<address>
<city>Little Rock</city>
<state>Arkansas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>California Pacific Medical Center</name>
<address>
<city>San Francisco</city>
<state>California</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Georgetown University</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Florida</name>
<address>
<city>Gainesville</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Illinois</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Iowa</name>
<address>
<city>Iowa City</city>
<state>Iowa</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Michigan State University</name>
<address>
<city>East Lansing</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University</name>
<address>
<city>New York</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Devers Eye Institute</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wills Eye Hospital</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Swedish Medical Center</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210</citation>
</reference>
<reference>
<citation>Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6.</citation>
<PMID>8500302</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7.</citation>
<PMID>8500303</PMID>
</reference>
<reference>
<citation>Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9.</citation>
<PMID>8932973</PMID>
</reference>
<reference>
<citation>Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)</citation>
</reference>
<reference>
<citation>Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52.</citation>
<PMID>9400788</PMID>
</reference>
<reference>
<citation>The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.</citation>
<PMID>1841573</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.</citation>
<PMID>1734247</PMID>
</reference>
<reference>
<citation>Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available.</citation>
<PMID>1318520</PMID>
</reference>
<reference>
<citation>Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available.</citation>
<PMID>1543448</PMID>
</reference>
<reference>
<citation>Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013.</citation>
<PMID>8352671</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023.</citation>
<PMID>8512477</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available.</citation>
<PMID>8447730</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA, Trobe JD, Kaufman DI, Kupersmith MJ, Paty DW, Brown CH. The effect of corticosteroids for acute optic neuritis on the subsequent development of multiple sclerosis. The Optic Neuritis Study Group. N Engl J Med. 1993 Dec 9;329(24):1764-9. doi: 10.1056/NEJM199312093292403.</citation>
<PMID>8232485</PMID>
</reference>
<reference>
<citation>Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9.</citation>
<PMID>8493012</PMID>
</reference>
<reference>
<citation>Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2.</citation>
<PMID>8468765</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029.</citation>
<PMID>8431161</PMID>
</reference>
<reference>
<citation>Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1.</citation>
<PMID>7800355</PMID>
</reference>
<reference>
<citation>Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027.</citation>
<PMID>8031275</PMID>
</reference>
<reference>
<citation>Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available.</citation>
<PMID>7864737</PMID>
</reference>
<reference>
<citation>Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available.</citation>
<PMID>8574355</PMID>
</reference>
<reference>
<citation>Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available.</citation>
<PMID>9097798</PMID>
</reference>
<reference>
<citation>Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368.</citation>
<PMID>8614496</PMID>
</reference>
<reference>
<citation>Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7.</citation>
<PMID>8610798</PMID>
</reference>
<reference>
<citation>Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1.</citation>
<PMID>9093956</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>May 26, 2006</last_update_submitted>
<last_update_submitted_qc>May 26, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">May 29, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Multiple Sclerosis</mesh_term>
<mesh_term>Neuritis</mesh_term>
<mesh_term>Optic Neuritis</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Prednisone</mesh_term>
<mesh_term>Methylprednisolone</mesh_term>
<mesh_term>Methylprednisolone Acetate</mesh_term>
<mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
<mesh_term>Prednisolone</mesh_term>
<mesh_term>Prednisolone acetate</mesh_term>
<mesh_term>Prednisolone hemisuccinate</mesh_term>
<mesh_term>Prednisolone phosphate</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000147
org study id: NEI-48
nct id: NCT00000147
lead sponsor:
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.
To determine the natural history of vision in patients who suffer optic neuritis.
To identify risk factors for the development of multiple sclerosis in patients with optic
neuritis.
Optic neuritis is an inflammatory disease of the optic nerve that typically affects young
adults. Women are affected more often than men. It is second only to glaucoma as the most
common acquired optic nerve disorder in persons younger than age 50.
In this disorder, closely linked to multiple sclerosis, prognosis for visual recovery is
generally good. However, return of visual function is almost never complete. After resolution
of optic neuritis, virtually all patients show some signs of optic nerve damage, and most are
symptomatic. Even when a patient's acuity recovers to 20/20, abnormalities frequently remain
in other measures such as contrast sensitivity, color vision, and visual field.
Prior to the Optic Neuritis Treatment Trial (ONTT), well-established guidelines for treating
optic neuritis did not exist. Although corticosteroids had been used to treat this disease,
studies to demonstrate their effectiveness had not been satisfactory. Some experts advocated
treatment with oral prednisone while others recommended no treatment. Anecdotal reports
suggested that high-dose intravenous corticosteroids might be effective.
The association between optic neuritis and multiple sclerosis is well established. Optic
neuritis may be the first manifestation of multiple sclerosis, or it may occur later in its
course. A strong case can be made for "isolated" optic neuritis being a forme fruste of
multiple sclerosis, based on similarities between the two in such epidemiologic factors as
gender, age, geographic distributions, cerebrospinal fluid changes, histocompatibility data,
magnetic resonance imaging (MRI) changes, and family history. The magnitude of the risk of
multiple sclerosis after optic neuritis is uncertain. Previous studies have reported very
disparate results, with the risk being reported to be as low as 13 percent and as high as 88
percent. The importance of risk factors such as age, gender, and MRI changes in predicting
which patients with optic neuritis are most likely to develop multiple sclerosis also is
unclear.
The treatment phase of the study was called the Optic Neuritis Treatment Trial (ONTT),
whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study
(LONS). The study is being conducted at 15 clinical centers in the United States. Resource
centers include a data coordinating center and a visual field reading center.
Patients were randomized to one of the three following treatment groups at 15 clinical
centers:
- Oral prednisone (1 mg/kg/day) for 14 days
- Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral
prednisone (1 mg/kg/day) for 11 days
- Oral placebo for 14 days.
Each regimen was followed by a short oral taper. The oral prednisone and placebo groups were
double masked, whereas the intravenous methylprednisolone group was single masked.
Baseline testing included blood tests to evaluate for syphilis and systemic lupus
erythematosus, a chest x-ray to evaluate for sarcoidosis, and a brain MRI scan to evaluate
for changes suggestive of multiple sclerosis.
The rate of visual recovery and the long-term visual outcome were both assessed by measures
of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven
followup visits during the first 6 months, and then yearly. A standardized neurologic
examination with an assessment of multiple sclerosis status was made at baseline, after 6
months, and then yearly.
primary purpose: Treatment
masking: Single
intervention type: Drug
intervention name: Methylprednisolone
intervention type: Drug
intervention name: Prednisone
criteria:
gender: All
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
citation: Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210
citation: Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6.
PMID: 8500302
citation: Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7.
PMID: 8500303
citation: Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9.
PMID: 8932973
citation: Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)
citation: Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52.
PMID: 9400788
citation: The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.
PMID: 1841573
citation: Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.
PMID: 1734247
citation: Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available.
PMID: 1318520
citation: Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available.
PMID: 1543448
citation: Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013.
PMID: 8352671
citation: Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023.
PMID: 8512477
citation: Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available.
PMID: 8447730
citation: Beck RW, Cleary PA, Trobe JD, Kaufman DI, Kupersmith MJ, Paty DW, Brown CH. The effect of corticosteroids for acute optic neuritis on the subsequent development of multiple sclerosis. The Optic Neuritis Study Group. N Engl J Med. 1993 Dec 9;329(24):1764-9. doi: 10.1056/NEJM199312093292403.
PMID: 8232485
citation: Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9.
PMID: 8493012
citation: Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2.
PMID: 8468765
citation: Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029.
PMID: 8431161
citation: Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1.
PMID: 7800355
citation: Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027.
PMID: 8031275
citation: Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available.
PMID: 7864737
citation: Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available.
PMID: 8574355
citation: Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available.
PMID: 9097798
citation: Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368.
PMID: 8614496
citation: Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7.
PMID: 8610798
citation: Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1.
PMID: 9093956
mesh term: Multiple Sclerosis
mesh term: Neuritis
mesh term: Optic Neuritis
mesh term: Prednisone
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
|
NCT0000xxxx/NCT00000148.xml
|
<clinical_study>
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https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000148</url>
</required_header>
<id_info>
<org_study_id>NEI-49</org_study_id>
<nct_id>NCT00000148</nct_id>
</id_info>
<brief_title>Advanced Glaucoma Intervention Study (AGIS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To assess the long-range outcomes of sequences of interventions involving trabeculectomy and
argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and
the eye has field defects. Before 1980, some type of filtering surgery, such as
trabeculectomy, was the usual method of intervention. Since then, laser trabeculoplasty has
become a popular alternative. Sometimes the first intervention chosen succeeds in controlling
pressure for many years; at other times, the success lasts only a few weeks or months.
Because success is limited, some patients, over time, need to undergo a sequence of surgical
interventions. Little is known about which sequence gives the best long-range outcome.

The Advanced Glaucoma Intervention Study (AGIS) is designed to provide a comprehensive
assessment of the long-range outcomes of medical and surgical management in advanced
glaucoma. The study uses visual function status to compare two intervention sequences in
managing the disease.

Eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy,
followed by argon laser trabeculoplasty (ALT) should trabeculectomy fail, followed by a
second trabeculectomy should ALT fail; or (2) ALT, followed by trabeculectomy should ALT
fail, followed by another trabeculectomy should the first trabeculectomy fail. Antifibrotic
agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history
of invasive surgery. Eyes that fail the entire assigned sequence of interventions are managed
at the discretion of the AGIS physician in collaboration with the patient.

Interventions are supplemented with medical treatment as needed. A total of 789 eyes with
advanced glaucoma have been enrolled. All patients are being followed under a standardized
protocol for a minimum of 5 years to determine degree of visual function loss, failure rates
of interventions, rates of complications, and need for supplemental therapy.

After the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3
months, 6 months, and every 6 months thereafter. After second and third interventions,
followup examinations are scheduled at 1 and 4 weeks. Additional visits are scheduled as
necessary for the management of the disease.

The primary outcome variable in AGIS is average percent of eyes with decrease of vision,
where decrease of vision is a substantial decline of either visual field or visual acuity
attributable to the effect of glaucoma. Secondary outcome variables include sustained
decrease of vision, failure of interventions, number of prescribed glaucoma medications, and
level of intraocular pressure. An ancillary study is assessing filtering bleb encapsulation.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>April 1988</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Glaucoma</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Laser Trabeculoplasty</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Trabeculectomy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women between the ages of 35 and 80 with open-angle glaucoma that was not
successfully controlled by medication were eligible for enrollment.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>35 Years</minimum_age>
<maximum_age>80 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>Yale University School of Medicine, Yale Eye Center</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Georgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory University, Emory Eye Center</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Piedmont Hospital, Eye Consultants of Atlanta</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Humana Health Plan Sykes Center</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Illinois, Eye and Ear Infirmary</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington Hospital Center, Washington Eye Physicians and Surgeons</name>
<address>
<city>Chevy Chase</city>
<state>Maryland</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan, W.K. Kellogg Eye Center</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sinai Hospital, Detroit, Franklin Eye Consultants</name>
<address>
<city>Southfield</city>
<state>Michigan</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Ohio State University, Department of Ophthalmology, Ophthalmic Surgeons and Consultants</name>
<address>
<city>Columbus</city>
<state>Ohio</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wills Eye Hospital, Glaucoma Service</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Virginia Medical Center, Department of Ophthalmology</name>
<address>
<city>Charlottesville</city>
<state>Virginia</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medical College of Virginia, Department of Ophthalmology</name>
<address>
<city>Richmond</city>
<state>Virginia</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/pr798.asp</url>
<description>NEI Press Release-Blacks, Whites Benefit from Different Surgical Glaucoma Treatments</description>
</link>
<reference>
<citation>The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192</citation>
</reference>
<reference>
<citation>Ederer F, Gaasterland DE, Sullivan EK; AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994 Aug;15(4):299-325. doi: 10.1016/0197-2456(94)90046-9.</citation>
<PMID>7956270</PMID>
</reference>
<reference>
<citation>Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.</citation>
<PMID>7741836</PMID>
</reference>
<reference>
<citation>The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120</citation>
</reference>
<reference>
<citation>The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. doi: 10.1016/s0161-6420(98)97012-9.</citation>
<PMID>9663214</PMID>
</reference>
<reference>
<citation>The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. doi: 10.1016/s0161-6420(98)97013-0.</citation>
<PMID>9663215</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 2, 2006</last_update_submitted>
<last_update_submitted_qc>June 2, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 5, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000148
org study id: NEI-49
nct id: NCT00000148
lead sponsor:
To assess the long-range outcomes of sequences of interventions involving trabeculectomy and
argon laser trabeculoplasty in eyes that have failed initial medical treatment for glaucoma.
In advanced glaucoma, medication alone no longer reduces intraocular pressure adequately, and
the eye has field defects. Before 1980, some type of filtering surgery, such as
trabeculectomy, was the usual method of intervention. Since then, laser trabeculoplasty has
become a popular alternative. Sometimes the first intervention chosen succeeds in controlling
pressure for many years; at other times, the success lasts only a few weeks or months.
Because success is limited, some patients, over time, need to undergo a sequence of surgical
interventions. Little is known about which sequence gives the best long-range outcome.
The Advanced Glaucoma Intervention Study (AGIS) is designed to provide a comprehensive
assessment of the long-range outcomes of medical and surgical management in advanced
glaucoma. The study uses visual function status to compare two intervention sequences in
managing the disease.
Eligible eyes are randomly assigned to one of two intervention sequences: (1) trabeculectomy,
followed by argon laser trabeculoplasty (ALT) should trabeculectomy fail, followed by a
second trabeculectomy should ALT fail; or (2) ALT, followed by trabeculectomy should ALT
fail, followed by another trabeculectomy should the first trabeculectomy fail. Antifibrotic
agents may be used as an adjunct to trabeculectomy, but only in eyes with a previous history
of invasive surgery. Eyes that fail the entire assigned sequence of interventions are managed
at the discretion of the AGIS physician in collaboration with the patient.
Interventions are supplemented with medical treatment as needed. A total of 789 eyes with
advanced glaucoma have been enrolled. All patients are being followed under a standardized
protocol for a minimum of 5 years to determine degree of visual function loss, failure rates
of interventions, rates of complications, and need for supplemental therapy.
After the initial intervention, followup examinations are scheduled at 1 week, 4 weeks, 3
months, 6 months, and every 6 months thereafter. After second and third interventions,
followup examinations are scheduled at 1 and 4 weeks. Additional visits are scheduled as
necessary for the management of the disease.
The primary outcome variable in AGIS is average percent of eyes with decrease of vision,
where decrease of vision is a substantial decline of either visual field or visual acuity
attributable to the effect of glaucoma. Secondary outcome variables include sustained
decrease of vision, failure of interventions, number of prescribed glaucoma medications, and
level of intraocular pressure. An ancillary study is assessing filtering bleb encapsulation.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Argon Laser Trabeculoplasty
intervention type: Procedure
intervention name: Trabeculectomy
criteria:
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/news/pressreleases/pr798.asp
description: NEI Press Release-Blacks, Whites Benefit from Different Surgical Glaucoma Treatments
citation: The Advanced Glaucoma Intervention Study (AGIS) Manual of Operations. Springfield, Virginia., National Technical Information Service, 1993;No. PB93-220192
citation: Ederer F, Gaasterland DE, Sullivan EK; AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994 Aug;15(4):299-325. doi: 10.1016/0197-2456(94)90046-9.
PMID: 7956270
citation: Advanced Glaucoma Intervention Study. 2. Visual field test scoring and reliability. Ophthalmology. 1994 Aug;101(8):1445-55.
PMID: 7741836
citation: The Advanced Glaucoma Intervention Study (AGIS) Data Management Handbook. Springfield, Virginia., National Technical Information Service, Document, 1996;No. PB96-137120
citation: The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients. Ophthalmology. 1998 Jul;105(7):1137-45. doi: 10.1016/s0161-6420(98)97012-9.
PMID: 9663214
citation: The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results. Ophthalmology. 1998 Jul;105(7):1146-64. doi: 10.1016/s0161-6420(98)97013-0.
PMID: 9663215
mesh term: Glaucoma
|
NCT0000xxxx/NCT00000149.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000149</url>
</required_header>
<id_info>
<org_study_id>NEI-50</org_study_id>
<nct_id>NCT00000149</nct_id>
</id_info>
<brief_title>Collaborative Initial Glaucoma Treatment Study (CIGTS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard
medical treatment versus filtration surgery.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Recent studies have challenged the conventional wisdom of treating all newly diagnosed
open-angle glaucoma (OAG) with eyedrops; rather, these studies suggest that more effective
control of glaucomatous damage can be obtained by immediate filtration surgery. In addition,
increased attention to the impact of therapy on health-related quality of life has added
another consideration in deciding upon appropriate treatment of such patients.

The Collaborative Initial Glaucoma Treatment Study (CIGTS), a randomized, controlled clinical
trial, is being conducted to determine whether patients with newly diagnosed OAG are best
managed by the conventional approach of topical pharmacologic agents or by immediate
filtration surgery. Eligible patients were randomized to receive either a stepped medication
treatment regimen or filtration surgery to control their OAG. Sample size requirements
indicated that 300 patients were needed for each treatment approach; a total of 607 patients
were ultimately recruited for the CIGTS.

Patients randomized to the medication treatment arm are receiving a stepped regimen of
topical medications, beginning with a single agent (typically a beta blocker), with
additional medications added upon documented lack of intraocular pressure control or evidence
of progressive visual field loss. If medications fail to control the patient's OAG, a series
of treatment steps begin with argon laser trabeculoplasty and conclude with trabeculectomy.

In the surgical treatment arm, patients underwent immediate trabeculectomy and, with
documented failure, proceed to argon laser trabeculectomy, then conclude with medications.
Patients, rather than eyes, are randomized to the two treatment arms; if both eyes are
eligible for treatment, the treatment course for both eyes is the same and was determined in
the randomization.

Following randomization, participating community ophthalmologists affiliated with the study
have been allowed to manage the medical and surgical care of study patients. However, all
patients are seen at the Clinical Centers for standardized followup examinations at 3 and 6
months after treatment and every 6 months thereafter; in addition, patients randomized to the
surgical arm will receive, at a minimum, postsurgical followup at 1 day, 1 week, and 1 month.
At the Clinical Center visits, examination of the eye(s) includes evaluation of visual
acuity, visual field, and intraocular pressure. The results of these tests determine whether
treatment should be changed. In addition, before and at regular intervals after treatment,
patients are being interviewed by telephone to assess their health-related quality of life. A
questionnaire that includes the Sickness Impact Profile, Visual Activities Questionnaire, and
other components is being used.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>October 1993</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Open-Angle Glaucoma</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Beta Blocker</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Trabeculectomy</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Laser Trabeculoplasty</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Patients must be at least 25 years old with an intraocular pressure of 20 mm Hg or greater
and evidence of optic nerve damage and/or visual field loss in one or both eyes. The ocular
findings must exclude causes of glaucoma other than primary open-angle glaucoma, pigmentary
glaucoma, or pseudoexfoliation glaucoma.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>25 Years</minimum_age>
<maximum_age>75 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Janz N; Wren PA; CIGTS Study Group; Implementing quality of life in a clinical trial, in Anderson DR, Drance SM (eds)., The Collaborative Initial Glaucoma Treatment Study. Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, 1996:45-62</citation>
</reference>
<reference>
<citation>Lichter PR; Mills RP; CIGTS Study Group; Quality of life study - determination of progression, in Anderson DR, Drance SM (eds)., Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, Amsterdam, Kugler Publications, 1996:149-163</citation>
</reference>
<reference>
<citation>Mills RP, Janz NK, Wren PA, Guire KE. Correlation of visual field with quality-of-life measures at diagnosis in the Collaborative Initial Glaucoma Treatment Study (CIGTS). J Glaucoma. 2001 Jun;10(3):192-8. doi: 10.1097/00061198-200106000-00008.</citation>
<PMID>11442181</PMID>
</reference>
<reference>
<citation>Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.</citation>
<PMID>11713061</PMID>
</reference>
<reference>
<citation>Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP; CIGTS Study Group. The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology. 2001 Nov;108(11):1954-65. doi: 10.1016/s0161-6420(01)00874-0.</citation>
<PMID>11713062</PMID>
</reference>
<reference>
<citation>Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE. Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2001 May;108(5):887-97; discussion 898. doi: 10.1016/s0161-6420(00)00624-2.</citation>
<PMID>11320018</PMID>
</reference>
<reference>
<citation>Musch DC, Lichter PR, Guire KE, Standardi CL. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999 Apr;106(4):653-62. doi: 10.1016/s0161-6420(99)90147-1.</citation>
<PMID>10201583</PMID>
</reference>
<verification_date>June 2002</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Glaucoma</mesh_term>
<mesh_term>Glaucoma, Open-Angle</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Adrenergic beta-Antagonists</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000149
org study id: NEI-50
nct id: NCT00000149
lead sponsor:
To compare the long-term effect of treating newly diagnosed open-angle glaucoma with standard
medical treatment versus filtration surgery.
Recent studies have challenged the conventional wisdom of treating all newly diagnosed
open-angle glaucoma (OAG) with eyedrops; rather, these studies suggest that more effective
control of glaucomatous damage can be obtained by immediate filtration surgery. In addition,
increased attention to the impact of therapy on health-related quality of life has added
another consideration in deciding upon appropriate treatment of such patients.
The Collaborative Initial Glaucoma Treatment Study (CIGTS), a randomized, controlled clinical
trial, is being conducted to determine whether patients with newly diagnosed OAG are best
managed by the conventional approach of topical pharmacologic agents or by immediate
filtration surgery. Eligible patients were randomized to receive either a stepped medication
treatment regimen or filtration surgery to control their OAG. Sample size requirements
indicated that 300 patients were needed for each treatment approach; a total of 607 patients
were ultimately recruited for the CIGTS.
Patients randomized to the medication treatment arm are receiving a stepped regimen of
topical medications, beginning with a single agent (typically a beta blocker), with
additional medications added upon documented lack of intraocular pressure control or evidence
of progressive visual field loss. If medications fail to control the patient's OAG, a series
of treatment steps begin with argon laser trabeculoplasty and conclude with trabeculectomy.
In the surgical treatment arm, patients underwent immediate trabeculectomy and, with
documented failure, proceed to argon laser trabeculectomy, then conclude with medications.
Patients, rather than eyes, are randomized to the two treatment arms; if both eyes are
eligible for treatment, the treatment course for both eyes is the same and was determined in
the randomization.
Following randomization, participating community ophthalmologists affiliated with the study
have been allowed to manage the medical and surgical care of study patients. However, all
patients are seen at the Clinical Centers for standardized followup examinations at 3 and 6
months after treatment and every 6 months thereafter; in addition, patients randomized to the
surgical arm will receive, at a minimum, postsurgical followup at 1 day, 1 week, and 1 month.
At the Clinical Center visits, examination of the eye(s) includes evaluation of visual
acuity, visual field, and intraocular pressure. The results of these tests determine whether
treatment should be changed. In addition, before and at regular intervals after treatment,
patients are being interviewed by telephone to assess their health-related quality of life. A
questionnaire that includes the Sickness Impact Profile, Visual Activities Questionnaire, and
other components is being used.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Beta Blocker
intervention type: Procedure
intervention name: Trabeculectomy
intervention type: Procedure
intervention name: Argon Laser Trabeculoplasty
criteria:
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
citation: Janz N; Wren PA; CIGTS Study Group; Implementing quality of life in a clinical trial, in Anderson DR, Drance SM (eds)., The Collaborative Initial Glaucoma Treatment Study. Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, 1996:45-62
citation: Lichter PR; Mills RP; CIGTS Study Group; Quality of life study - determination of progression, in Anderson DR, Drance SM (eds)., Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, Amsterdam, Kugler Publications, 1996:149-163
citation: Mills RP, Janz NK, Wren PA, Guire KE. Correlation of visual field with quality-of-life measures at diagnosis in the Collaborative Initial Glaucoma Treatment Study (CIGTS). J Glaucoma. 2001 Jun;10(3):192-8. doi: 10.1097/00061198-200106000-00008.
PMID: 11442181
citation: Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
PMID: 11713061
citation: Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP; CIGTS Study Group. The Collaborative Initial Glaucoma Treatment Study: interim quality of life findings after initial medical or surgical treatment of glaucoma. Ophthalmology. 2001 Nov;108(11):1954-65. doi: 10.1016/s0161-6420(01)00874-0.
PMID: 11713062
citation: Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE. Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Ophthalmology. 2001 May;108(5):887-97; discussion 898. doi: 10.1016/s0161-6420(00)00624-2.
PMID: 11320018
citation: Musch DC, Lichter PR, Guire KE, Standardi CL. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999 Apr;106(4):653-62. doi: 10.1016/s0161-6420(99)90147-1.
PMID: 10201583
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Adrenergic beta-Antagonists
|
NCT0000xxxx/NCT00000150.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000150</url>
</required_header>
<id_info>
<org_study_id>NEI-52</org_study_id>
<nct_id>NCT00000150</nct_id>
</id_info>
<brief_title>Submacular Surgery Trials (SST)</brief_title>
<official_title>Submacular Surgery Trials (SST)</official_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and
associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular
histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often
than observation.

To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS,
or idiopathic causes changes the patient's perception of health- and vision-related "quality
of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36
(MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye
Institute Visual Function Questionnaire (NEI VFQ-25).

To determine whether randomized trials of surgery are warranted for patients with subfoveal
CNV associated with age-related macular degeneration not suitable for laser treatment.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Age-related macular degeneration (AMD) with CNV is the most common cause of irreversible
severe loss of vision in older adults. The Macular Photocoagulation Study (MPS) Group,
sponsored by the National Eye Institute, demonstrated that laser treatment is effective for
recurrent subfoveal CNV (that extends into the center of the macula) after laser treatment
and for selected patients with subfoveal CNV who had no prior treatment. More recently,
photodynamic therapy with verteporfin was shown to reduce the risk of moderate and server
loss of vision in selected patients with subfoveal neovascularization associated with AMD.
Choroidal neovascularization due to OHS affects adults of working age and may pose a lifelong
risk of blindness to people who have characteristic scars ("histo spots") in the macula. It
has been estimated that 2,000,000 people who live or have lived in the region of the United
States in which histoplasmosis is endemic have characteristic histo spots and that 100,000 of
them will lose vision in one or both eyes due to CNV. Fortunately, the effectiveness of laser
photocoagulation for treating CNV due to OHS that is not subfoveal (i.e., not extending into
the center of the macula) also has been demonstrated by the MPS Group in two randomized
clinical trials. However, treated patients are at risk of subfoveal recurrence, and laser
treatment cannot be applied to these patients or to other patients with OHS who present with
subfoveal CNV in the absence of prior laser treatment.

Recently, alternative therapies to laser photocoagulation and photodynamic therapy have been
proposed for the management of CNV and are intended to increase the chance of stabilizing or
improving vision at a greater rate than with observation. The most promising of these
alternatives at this time is surgical removal of the neovascular lesion, i.e., submacular
surgery. The rationale for this surgical approach is that removal of the CNV may halt
enlargement of the visual defect, spare photoreceptors in the central macula, and allow
adjacent ocular structures to function normally. Data regarding the effectiveness of this
approach is limited to reports of case series which suffer from the absence of untreated
controls, limited number of cases evaluated, or lack of long term follow-up to assess the
impact of recurrent CNV, delayed atrophy of the outer retina, and adverse outcomes such as
cataract and retinal detachment, requiring additional treatment.

The Submacular Surgery Trials comprise a set of multicenter, randomized clinical trials with
the goal of determining whether surgical removal of subfoveal CNV stabilizes or improves
vision more often than observation. A total of 19 clinical centers collaborated in conducting
a clinical trial for patients with neovascular OHS and idiopathic CNV (Group H protocol). The
target sample size for the Group H protocol was 250 participants to be enrolled and followed
for 4 years. A total of 29 clinical centers collaborated in conducting two additional
clinical trials for patients with neovascular AMD. The target sample size for these AMD
trials was 960 participants to be enrolled and followed for 4 years.

Vision data collected at baseline include a protocol refraction, best-corrected logMAR visual
acuity (ETDRS charts), contrast threshold (Pelli-Robson charts), and reading speed (enlarged
text). Other baseline data recorded include stereoscopic color fundus photographs,
fluorescein angiograms, and lens photographs, as well as health- and vision-related quality
of life interview data (by telephone).

Eligible patients who gave signed, informed consent were randomly assigned to surgery (within
8 days of randomization) or observation. Patients, assigned to surgery, are seen one month
post-surgery for an examination and photographs. All participants are examined at 3, 6, 12,
24, 36, and 48 months after randomization to collect vision data (collected in a masked
fashion at 24 and 48 months after randomization) and to repeat photography. Quality of life
telephone interviews are repeated at 6, 12, 24, 36, and 48 months after randomization.

The primary outcome is improvement in visual acuity from baseline to the two-year examination
or retention of baseline visual acuity through the two-year examination. Secondary outcomes
include change in quality of life from baseline to the 2- and 4-year examinations, change in
visual acuity over 4 years, large losses of visual acuity, and adverse ocular outcomes (e.g.,
those requiring additional treatment such as cataract, retinal detachment, or recurrent CNV).
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1999</start_date>
<completion_date>September 2001</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Macular Degeneration</condition>
<condition>Histoplasmosis</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Subfoveal Choroidal Neovascularization Removal</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Group B: Patients with evidence of large hemorrhages from subfoveal neovascular AMD
lesions, visual acuity (SST protocol) of 20/100 to light perception, with the area of
hemorrhage larger than the area of fluorescein angiographically visible CNV, with any
visible CNV less than or equal to 9 MPS disc areas, and ability to return for 4 years of
follow-up may be eligible for the Group B (Blood) protocol.

Group N: Patients with new CNV (no prior laser) due to AMD, visual acuity (SST protocol) of
20/100 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion which is less
than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be
eligible for the Group N (New CNV) protocol.

Group H: Patients with evidence of CNV due to OHS or idiopathic cause, visual acuity (SST
protocol) 20/50 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion (new
or recurrent) which is < 9 MPS disc areas, and ability to return for 4 years of follow-up
may be eligible for inclusion in the Group H (Histoplasmosis/Idiopathic CNV) protocol.
Exclusion criteria include other ocular diseases compromising vision, history of submacular
surgery in the study eye, history of subfoveal laser photocoagulation that extends under
the foveal avascular zone, recent intraocular surgery, or previous investigational therapy
for CNV.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Grossniklaus HE, Green WR. Histopathologic and ultrastructural findings of surgically excised choroidal neovascularization. Submacular Surgery Trials Research Group. Arch Ophthalmol. 1998 Jun;116(6):745-9. doi: 10.1001/archopht.116.6.745.</citation>
<PMID>9639442</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Ocular Histoplasmosis Syndrome</keyword>
<keyword>Idiopathic Choroidal Neovascularization</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Histoplasmosis</mesh_term>
<mesh_term>Macular Degeneration</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000150
org study id: NEI-52
nct id: NCT00000150
lead sponsor:
To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and
associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular
histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often
than observation.
To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS,
or idiopathic causes changes the patient's perception of health- and vision-related "quality
of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36
(MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye
Institute Visual Function Questionnaire (NEI VFQ-25).
To determine whether randomized trials of surgery are warranted for patients with subfoveal
CNV associated with age-related macular degeneration not suitable for laser treatment.
Age-related macular degeneration (AMD) with CNV is the most common cause of irreversible
severe loss of vision in older adults. The Macular Photocoagulation Study (MPS) Group,
sponsored by the National Eye Institute, demonstrated that laser treatment is effective for
recurrent subfoveal CNV (that extends into the center of the macula) after laser treatment
and for selected patients with subfoveal CNV who had no prior treatment. More recently,
photodynamic therapy with verteporfin was shown to reduce the risk of moderate and server
loss of vision in selected patients with subfoveal neovascularization associated with AMD.
Choroidal neovascularization due to OHS affects adults of working age and may pose a lifelong
risk of blindness to people who have characteristic scars ("histo spots") in the macula. It
has been estimated that 2,000,000 people who live or have lived in the region of the United
States in which histoplasmosis is endemic have characteristic histo spots and that 100,000 of
them will lose vision in one or both eyes due to CNV. Fortunately, the effectiveness of laser
photocoagulation for treating CNV due to OHS that is not subfoveal (i.e., not extending into
the center of the macula) also has been demonstrated by the MPS Group in two randomized
clinical trials. However, treated patients are at risk of subfoveal recurrence, and laser
treatment cannot be applied to these patients or to other patients with OHS who present with
subfoveal CNV in the absence of prior laser treatment.
Recently, alternative therapies to laser photocoagulation and photodynamic therapy have been
proposed for the management of CNV and are intended to increase the chance of stabilizing or
improving vision at a greater rate than with observation. The most promising of these
alternatives at this time is surgical removal of the neovascular lesion, i.e., submacular
surgery. The rationale for this surgical approach is that removal of the CNV may halt
enlargement of the visual defect, spare photoreceptors in the central macula, and allow
adjacent ocular structures to function normally. Data regarding the effectiveness of this
approach is limited to reports of case series which suffer from the absence of untreated
controls, limited number of cases evaluated, or lack of long term follow-up to assess the
impact of recurrent CNV, delayed atrophy of the outer retina, and adverse outcomes such as
cataract and retinal detachment, requiring additional treatment.
The Submacular Surgery Trials comprise a set of multicenter, randomized clinical trials with
the goal of determining whether surgical removal of subfoveal CNV stabilizes or improves
vision more often than observation. A total of 19 clinical centers collaborated in conducting
a clinical trial for patients with neovascular OHS and idiopathic CNV (Group H protocol). The
target sample size for the Group H protocol was 250 participants to be enrolled and followed
for 4 years. A total of 29 clinical centers collaborated in conducting two additional
clinical trials for patients with neovascular AMD. The target sample size for these AMD
trials was 960 participants to be enrolled and followed for 4 years.
Vision data collected at baseline include a protocol refraction, best-corrected logMAR visual
acuity (ETDRS charts), contrast threshold (Pelli-Robson charts), and reading speed (enlarged
text). Other baseline data recorded include stereoscopic color fundus photographs,
fluorescein angiograms, and lens photographs, as well as health- and vision-related quality
of life interview data (by telephone).
Eligible patients who gave signed, informed consent were randomly assigned to surgery (within
8 days of randomization) or observation. Patients, assigned to surgery, are seen one month
post-surgery for an examination and photographs. All participants are examined at 3, 6, 12,
24, 36, and 48 months after randomization to collect vision data (collected in a masked
fashion at 24 and 48 months after randomization) and to repeat photography. Quality of life
telephone interviews are repeated at 6, 12, 24, 36, and 48 months after randomization.
The primary outcome is improvement in visual acuity from baseline to the two-year examination
or retention of baseline visual acuity through the two-year examination. Secondary outcomes
include change in quality of life from baseline to the 2- and 4-year examinations, change in
visual acuity over 4 years, large losses of visual acuity, and adverse ocular outcomes (e.g.,
those requiring additional treatment such as cataract, retinal detachment, or recurrent CNV).
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Subfoveal Choroidal Neovascularization Removal
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Grossniklaus HE, Green WR. Histopathologic and ultrastructural findings of surgically excised choroidal neovascularization. Submacular Surgery Trials Research Group. Arch Ophthalmol. 1998 Jun;116(6):745-9. doi: 10.1001/archopht.116.6.745.
PMID: 9639442
mesh term: Histoplasmosis
mesh term: Macular Degeneration
|
NCT0000xxxx/NCT00000151.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000151</url>
</required_header>
<id_info>
<org_study_id>NEI-53</org_study_id>
<nct_id>NCT00000151</nct_id>
</id_info>
<brief_title>Early Treatment Diabetic Retinopathy Study (ETDRS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in
delaying or preventing progression of early diabetic retinopathy to more severe stages of
visual loss and blindness.

To help determine the best time to initiate photocoagulation treatment in diabetic
retinopathy.

To monitor closely the effects of diabetes mellitus and of photocoagulation on visual
function.

To produce natural history data that can be used to identify risk factors and test etiologic
hypotheses in diabetic retinopathy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
ETDRS was a multicenter, randomized clinical trial designed to evaluate argon laser
photocoagulation and aspirin treatment in the management of patients with nonproliferative or
early proliferative diabetic retinopathy. A total of 3,711 patients were recruited to be
followed for a minimum of 4 years to provide long-term information on the risks and benefits
of the treatments under study.

The eligibility criteria for the ETDRS were designed to include a broad range of macular
edema severity, from a few small hard exudates within a disc diameter of the fovea with
normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study
patients had one eye randomly assigned to immediate photocoagulation and the other eye to
deferral of photocoagulation until high-risk proliferative retinopathy developed. During
followup, additional photocoagulation was allowed for any degree of macular edema within the
eligibility range, but additional photocoagulation was required only for edema involving or
threatening the center of the macula. The term "clinically significant macular edema" was
coined to designate this level of severity.

The trial use of aspirin therapy was based on clinical observation and on aspirin's possible
mechanisms of action. Previous observations of diabetic patients who were taking large doses
of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group
was lower than the prevalence that would be expected in the diabetic population at large.
Evidence suggested that diabetic patients have altered platelet aggregation and
disaggregation, which may contribute to the capillary closure seen in retinopathy. This
abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible
mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and
intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and
monitored.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1979</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Blindness</condition>
<condition>Diabetic Retinopathy</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aspirin</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Laser Photocoagulation</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women between the ages of 18 and 70 years with moderate or severe nonproliferative
diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous
photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if
macular edema is present) were eligible for this study.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/clinicalalerts/alert-etdrs.asp</url>
<description>Clinical Alert to Ophthalmologists-Early Treatment Diabetic Retinopathy Study (ETDRS)</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/030993.asp</url>
<description>NEI Press Release-ETDRS 5-Year Followup Data Released</description>
</link>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/edtrspressrelease.asp</url>
<description>NEI Press Release-Laser Treatment Highly Effective in Treating Diabetic Retinopathy</description>
</link>
<reference>
<citation>Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74. doi: 10.1016/s0161-6420(87)33527-4.</citation>
<PMID>3658348</PMID>
</reference>
<reference>
<citation>Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: Early Treatment Diabetic Retinopathy Study Report no. 3. The Early Treatment Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):254-64. doi: 10.1097/00004397-198702740-00005. No abstract available.</citation>
<PMID>3692707</PMID>
</reference>
<reference>
<citation>Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7. Ophthalmology. 1991 May;98(5 Suppl):741-56. doi: 10.1016/s0161-6420(13)38009-9.</citation>
<PMID>2062510</PMID>
</reference>
<reference>
<citation>Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.</citation>
<PMID>2866759</PMID>
</reference>
<reference>
<citation>Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study Report no. 4. The Early Treatment Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):265-72. doi: 10.1097/00004397-198702740-00006. No abstract available.</citation>
<PMID>3692708</PMID>
</reference>
<reference>
<citation>Kinyoun J, Barton F, Fisher M, Hubbard L, Aiello L, Ferris F 3rd. Detection of diabetic macular edema. Ophthalmoscopy versus photography--Early Treatment Diabetic Retinopathy Study Report Number 5. The ETDRS Research Group. Ophthalmology. 1989 Jun;96(6):746-50; discussion 750-1. doi: 10.1016/s0161-6420(89)32814-4.</citation>
<PMID>2740076</PMID>
</reference>
<reference>
<citation>Effects of aspirin treatment on diabetic retinopathy. ETDRS report number 8. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):757-65.</citation>
<PMID>2062511</PMID>
</reference>
<reference>
<citation>Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.</citation>
<PMID>2062512</PMID>
</reference>
<reference>
<citation>Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.</citation>
<PMID>2062513</PMID>
</reference>
<reference>
<citation>Classification of diabetic retinopathy from fluorescein angiograms. ETDRS report number 11. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):807-22.</citation>
<PMID>2062514</PMID>
</reference>
<reference>
<citation>Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.</citation>
<PMID>2062515</PMID>
</reference>
<reference>
<citation>Fluorescein angiographic risk factors for progression of diabetic retinopathy. ETDRS report number 13. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):834-40.</citation>
<PMID>2062516</PMID>
</reference>
<reference>
<citation>Aspirin effects on mortality and morbidity in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report 14. ETDRS Investigators. JAMA. 1992 Sep 9;268(10):1292-300. doi: 10.1001/jama.1992.03490100090033.</citation>
<PMID>1507375</PMID>
</reference>
<reference>
<citation>Chew EY, Williams GA, Burton TC, Barton FB, Remaley NA, Ferris FL 3rd. Aspirin effects on the development of cataracts in patients with diabetes mellitus. Early treatment diabetic retinopathy study report 16. Arch Ophthalmol. 1992 Mar;110(3):339-42. doi: 10.1001/archopht.1992.01080150037023.</citation>
<PMID>1543449</PMID>
</reference>
<reference>
<citation>Flynn HW Jr, Chew EY, Simons BD, Barton FB, Remaley NA, Ferris FL 3rd. Pars plana vitrectomy in the Early Treatment Diabetic Retinopathy Study. ETDRS report number 17. The Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1992 Sep;99(9):1351-7. doi: 10.1016/s0161-6420(92)31779-8.</citation>
<PMID>1407968</PMID>
</reference>
<reference>
<citation>Prior MJ, Prout T, Miller D, Ewart R, Kumar D. C-peptide and the classification of diabetes mellitus patients in the Early Treatment Diabetic Retinopathy Study. Report number 6. The ETDRS Research Group. Ann Epidemiol. 1993 Jan;3(1):9-17. doi: 10.1016/1047-2797(93)90004-n.</citation>
<PMID>8287162</PMID>
</reference>
<reference>
<citation>Chew EY, Klein ML, Murphy RP, Remaley NA, Ferris FL 3rd. Effects of aspirin on vitreous/preretinal hemorrhage in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report no. 20. Arch Ophthalmol. 1995 Jan;113(1):52-5. doi: 10.1001/archopht.1995.01100010054020.</citation>
<PMID>7826294</PMID>
</reference>
<reference>
<citation>Focal photocoagulation treatment of diabetic macular edema. Relationship of treatment effect to fluorescein angiographic and other retinal characteristics at baseline: ETDRS report no. 19. Early Treatment Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1995 Sep;113(9):1144-55.</citation>
<PMID>7661748</PMID>
</reference>
<reference>
<citation>Chew EY, Klein ML, Ferris FL 3rd, Remaley NA, Murphy RP, Chantry K, Hoogwerf BJ, Miller D. Association of elevated serum lipid levels with retinal hard exudate in diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) Report 22. Arch Ophthalmol. 1996 Sep;114(9):1079-84. doi: 10.1001/archopht.1996.01100140281004.</citation>
<PMID>8790092</PMID>
</reference>
<reference>
<citation>Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37.</citation>
<PMID>8981711</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 1, 2006</last_update_submitted>
<last_update_submitted_qc>September 1, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">September 4, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Blindness</mesh_term>
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Diabetic Retinopathy</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aspirin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000151
org study id: NEI-53
nct id: NCT00000151
lead sponsor:
To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in
delaying or preventing progression of early diabetic retinopathy to more severe stages of
visual loss and blindness.
To help determine the best time to initiate photocoagulation treatment in diabetic
retinopathy.
To monitor closely the effects of diabetes mellitus and of photocoagulation on visual
function.
To produce natural history data that can be used to identify risk factors and test etiologic
hypotheses in diabetic retinopathy.
ETDRS was a multicenter, randomized clinical trial designed to evaluate argon laser
photocoagulation and aspirin treatment in the management of patients with nonproliferative or
early proliferative diabetic retinopathy. A total of 3,711 patients were recruited to be
followed for a minimum of 4 years to provide long-term information on the risks and benefits
of the treatments under study.
The eligibility criteria for the ETDRS were designed to include a broad range of macular
edema severity, from a few small hard exudates within a disc diameter of the fovea with
normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study
patients had one eye randomly assigned to immediate photocoagulation and the other eye to
deferral of photocoagulation until high-risk proliferative retinopathy developed. During
followup, additional photocoagulation was allowed for any degree of macular edema within the
eligibility range, but additional photocoagulation was required only for edema involving or
threatening the center of the macula. The term "clinically significant macular edema" was
coined to designate this level of severity.
The trial use of aspirin therapy was based on clinical observation and on aspirin's possible
mechanisms of action. Previous observations of diabetic patients who were taking large doses
of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group
was lower than the prevalence that would be expected in the diabetic population at large.
Evidence suggested that diabetic patients have altered platelet aggregation and
disaggregation, which may contribute to the capillary closure seen in retinopathy. This
abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible
mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and
intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and
monitored.
allocation: Randomized
primary purpose: Treatment
intervention type: Drug
intervention name: Aspirin
intervention type: Procedure
intervention name: Argon Laser Photocoagulation
criteria:
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
url: http://www.nei.nih.gov/news/clinicalalerts/alert-etdrs.asp
description: Clinical Alert to Ophthalmologists-Early Treatment Diabetic Retinopathy Study (ETDRS)
url: http://www.nei.nih.gov/news/pressreleases/030993.asp
description: NEI Press Release-ETDRS 5-Year Followup Data Released
url: http://www.nei.nih.gov/news/pressreleases/edtrspressrelease.asp
description: NEI Press Release-Laser Treatment Highly Effective in Treating Diabetic Retinopathy
citation: Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74. doi: 10.1016/s0161-6420(87)33527-4.
PMID: 3658348
citation: Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: Early Treatment Diabetic Retinopathy Study Report no. 3. The Early Treatment Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):254-64. doi: 10.1097/00004397-198702740-00005. No abstract available.
PMID: 3692707
citation: Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7. Ophthalmology. 1991 May;98(5 Suppl):741-56. doi: 10.1016/s0161-6420(13)38009-9.
PMID: 2062510
citation: Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
PMID: 2866759
citation: Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study Report no. 4. The Early Treatment Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):265-72. doi: 10.1097/00004397-198702740-00006. No abstract available.
PMID: 3692708
citation: Kinyoun J, Barton F, Fisher M, Hubbard L, Aiello L, Ferris F 3rd. Detection of diabetic macular edema. Ophthalmoscopy versus photography--Early Treatment Diabetic Retinopathy Study Report Number 5. The ETDRS Research Group. Ophthalmology. 1989 Jun;96(6):746-50; discussion 750-1. doi: 10.1016/s0161-6420(89)32814-4.
PMID: 2740076
citation: Effects of aspirin treatment on diabetic retinopathy. ETDRS report number 8. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):757-65.
PMID: 2062511
citation: Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
PMID: 2062512
citation: Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806.
PMID: 2062513
citation: Classification of diabetic retinopathy from fluorescein angiograms. ETDRS report number 11. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):807-22.
PMID: 2062514
citation: Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):823-33.
PMID: 2062515
citation: Fluorescein angiographic risk factors for progression of diabetic retinopathy. ETDRS report number 13. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):834-40.
PMID: 2062516
citation: Aspirin effects on mortality and morbidity in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report 14. ETDRS Investigators. JAMA. 1992 Sep 9;268(10):1292-300. doi: 10.1001/jama.1992.03490100090033.
PMID: 1507375
citation: Chew EY, Williams GA, Burton TC, Barton FB, Remaley NA, Ferris FL 3rd. Aspirin effects on the development of cataracts in patients with diabetes mellitus. Early treatment diabetic retinopathy study report 16. Arch Ophthalmol. 1992 Mar;110(3):339-42. doi: 10.1001/archopht.1992.01080150037023.
PMID: 1543449
citation: Flynn HW Jr, Chew EY, Simons BD, Barton FB, Remaley NA, Ferris FL 3rd. Pars plana vitrectomy in the Early Treatment Diabetic Retinopathy Study. ETDRS report number 17. The Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1992 Sep;99(9):1351-7. doi: 10.1016/s0161-6420(92)31779-8.
PMID: 1407968
citation: Prior MJ, Prout T, Miller D, Ewart R, Kumar D. C-peptide and the classification of diabetes mellitus patients in the Early Treatment Diabetic Retinopathy Study. Report number 6. The ETDRS Research Group. Ann Epidemiol. 1993 Jan;3(1):9-17. doi: 10.1016/1047-2797(93)90004-n.
PMID: 8287162
citation: Chew EY, Klein ML, Murphy RP, Remaley NA, Ferris FL 3rd. Effects of aspirin on vitreous/preretinal hemorrhage in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report no. 20. Arch Ophthalmol. 1995 Jan;113(1):52-5. doi: 10.1001/archopht.1995.01100010054020.
PMID: 7826294
citation: Focal photocoagulation treatment of diabetic macular edema. Relationship of treatment effect to fluorescein angiographic and other retinal characteristics at baseline: ETDRS report no. 19. Early Treatment Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1995 Sep;113(9):1144-55.
PMID: 7661748
citation: Chew EY, Klein ML, Ferris FL 3rd, Remaley NA, Murphy RP, Chantry K, Hoogwerf BJ, Miller D. Association of elevated serum lipid levels with retinal hard exudate in diabetic retinopathy. Early Treatment Diabetic Retinopathy Study (ETDRS) Report 22. Arch Ophthalmol. 1996 Sep;114(9):1079-84. doi: 10.1001/archopht.1996.01100140281004.
PMID: 8790092
citation: Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37.
PMID: 8981711
mesh term: Blindness
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Aspirin
|
NCT0000xxxx/NCT00000152.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000152</url>
</required_header>
<id_info>
<org_study_id>NEI-54</org_study_id>
<nct_id>NCT00000152</nct_id>
</id_info>
<brief_title>Randomized Trial of Beta-Carotene and Macular Degeneration</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether 50 mg of beta-carotene taken every other day reduces the risk of
developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40
to 84 in 1982.

To investigate the possible relationship of AMD with other antioxidants, including selenium
and vitamins A, C, and E.

To identify potential risk factors for development of AMD. Possible risk factors include
height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking,
iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Macular degeneration, a major cause of blindness in the United States, is the leading cause
of new cases of blindness in people aged 65 and older. The National Eye Institute estimates
that each year an additional 165,000 people, mainly in the older age groups, develop macular
disease. Among all people with macular degeneration, approximately 116,000 are affected by
the neovascular form of the disease. Although laser treatment is an effective treatment for
patients with certain forms of neovascular membranes (exudative AMD), for most patients there
is no available treatment.

The pathogenesis of AMD is only partly understood, and its etiology remains obscure. The
Retinal and Choroidal Diseases Panel of the National Advisory Eye Council has stated that
"none of the fundamental causes of any type of macular disease is known, and none can be
prevented." Thus, this panel recommended that one of the NEI's program development priorities
should be to "initiate epidemiologic studies of macular diseases to identify possible
causative, protective, or aggravating factors."

This trial is part of the Physicians Health Study, sponsored by the National Heart, Lung, and
Blood Institute (NHLBI) of the National Institutes of Health, with funding for eye
epidemiologic data evaluations provided by the NEI. It is an ongoing, randomized,
placebo-controlled trial of aspirin in the prevention of cardiovascular mortality and of
beta-carotene in the prevention of cancer. Following randomization, each of the 22,071
physicians enrolled was assigned to one of four groups to take either aspirin or its placebo
and beta-carotene or its placebo. Followup questionnaires are sent 6 and 12 months after
randomization and every 12 months thereafter. The average length of followup is now greater
than 12 years.

The hypothesis that beta-carotene levels are inversely related to AMD is supported by
experimental studies on the relationship between antioxidants and retinal morphology and
function. There is increasing evidence that visible and ultraviolet light can damage the
retina through production of superoxide radicals. Antioxidants (including beta-carotene,
vitamins A, E, and C, and selenium) protect against oxidative damage by acting as scavengers
for the superoxide radicals.

Epidemiologic data from the first National Health and Nutrition Examination Survey (NHANES-1)
are also consistent with a link between antioxidants and AMD; the frequency of consumption of
fruits and vegetables rich in vitamin A (beta-carotene) was negatively correlated with AMD
after adjustment for demographic and medical factors.

Data from this study will determine whether one 50-mg beta-carotene capsule taken on
alternate days protects against the development of AMD and whether additional risk factors
emerge after simultaneous controlling for other potential confounding factors.

Reported diagnoses of AMD are confirmed by medical record review. The primary analysis will
be a comparison of incidence of reported AMD in the beta-carotene and placebo groups. The Cox
proportional hazards model will also be used to determine whether there is a difference in
time to diagnosis of AMD between the two groups.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>April 1982</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Prevention</primary_purpose>
</study_design_info>
<condition>Macular Degeneration</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aspirin</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Beta-Carotene</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
When the Physicians Health Study was established in the early 1980s by the NHLBI to collect
data on a stable population at risk for heart attack, only male physicians were studied
because males were thought to be at higher risk than females for ischemic heart problems.
The study population consists of 22,071 male U.S. physicians who were aged 40 to 84 years
in 1982. The subjects have no history of myocardial infarction, cancer, kidney disease,
renal disease, or any other contraindication to the use of aspirin or beta-carotene,
including regular use of corticosteroids.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>84 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<verification_date>September 2001</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Age-Related Macular Degeneration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Degeneration</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aspirin</mesh_term>
<mesh_term>Beta Carotene</mesh_term>
<mesh_term>Carotenoids</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000152
org study id: NEI-54
nct id: NCT00000152
lead sponsor:
To determine whether 50 mg of beta-carotene taken every other day reduces the risk of
developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40
to 84 in 1982.
To investigate the possible relationship of AMD with other antioxidants, including selenium
and vitamins A, C, and E.
To identify potential risk factors for development of AMD. Possible risk factors include
height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking,
iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
Macular degeneration, a major cause of blindness in the United States, is the leading cause
of new cases of blindness in people aged 65 and older. The National Eye Institute estimates
that each year an additional 165,000 people, mainly in the older age groups, develop macular
disease. Among all people with macular degeneration, approximately 116,000 are affected by
the neovascular form of the disease. Although laser treatment is an effective treatment for
patients with certain forms of neovascular membranes (exudative AMD), for most patients there
is no available treatment.
The pathogenesis of AMD is only partly understood, and its etiology remains obscure. The
Retinal and Choroidal Diseases Panel of the National Advisory Eye Council has stated that
"none of the fundamental causes of any type of macular disease is known, and none can be
prevented." Thus, this panel recommended that one of the NEI's program development priorities
should be to "initiate epidemiologic studies of macular diseases to identify possible
causative, protective, or aggravating factors."
This trial is part of the Physicians Health Study, sponsored by the National Heart, Lung, and
Blood Institute (NHLBI) of the National Institutes of Health, with funding for eye
epidemiologic data evaluations provided by the NEI. It is an ongoing, randomized,
placebo-controlled trial of aspirin in the prevention of cardiovascular mortality and of
beta-carotene in the prevention of cancer. Following randomization, each of the 22,071
physicians enrolled was assigned to one of four groups to take either aspirin or its placebo
and beta-carotene or its placebo. Followup questionnaires are sent 6 and 12 months after
randomization and every 12 months thereafter. The average length of followup is now greater
than 12 years.
The hypothesis that beta-carotene levels are inversely related to AMD is supported by
experimental studies on the relationship between antioxidants and retinal morphology and
function. There is increasing evidence that visible and ultraviolet light can damage the
retina through production of superoxide radicals. Antioxidants (including beta-carotene,
vitamins A, E, and C, and selenium) protect against oxidative damage by acting as scavengers
for the superoxide radicals.
Epidemiologic data from the first National Health and Nutrition Examination Survey (NHANES-1)
are also consistent with a link between antioxidants and AMD; the frequency of consumption of
fruits and vegetables rich in vitamin A (beta-carotene) was negatively correlated with AMD
after adjustment for demographic and medical factors.
Data from this study will determine whether one 50-mg beta-carotene capsule taken on
alternate days protects against the development of AMD and whether additional risk factors
emerge after simultaneous controlling for other potential confounding factors.
Reported diagnoses of AMD are confirmed by medical record review. The primary analysis will
be a comparison of incidence of reported AMD in the beta-carotene and placebo groups. The Cox
proportional hazards model will also be used to determine whether there is a difference in
time to diagnosis of AMD between the two groups.
allocation: Randomized
primary purpose: Prevention
intervention type: Drug
intervention name: Aspirin
intervention type: Drug
intervention name: Beta-Carotene
criteria:
gender: Male
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: Accepts Healthy Volunteers
mesh term: Macular Degeneration
mesh term: Aspirin
mesh term: Beta Carotene
mesh term: Carotenoids
|
NCT0000xxxx/NCT00000153.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000153</url>
</required_header>
<id_info>
<org_study_id>NEI-55</org_study_id>
<nct_id>NCT00000153</nct_id>
</id_info>
<brief_title>Krypton-Argon Regression of Neovascularization Study (KARNS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate whether red krypton laser treatment is as effective at causing regression of
diabetic disc neovascularization as treatment with the blue-green argon laser, when both
lasers are used with identical panretinal photocoagulation patterns.

To assess the vision of study patients.

To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which
participating clinics are not financially reimbursed and in which both the Coordinating and
Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and
Epidemiology Program.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The KARNS was a randomized clinical trial designed to compare the effectiveness of argon and
krypton laser photocoagulation in causing the regression of preexisting neovascularization on
the disc (NVD) in diabetic retinopathy. The main theoretical advantage for the krypton laser
in the treatment of diabetic retinopathy is that the red laser beam penetrates blood and may
be more effective in making burns in the pigment epithelium in eyes with vitreous hemorrhage.

The burns produced by the krypton laser in the retina are different from those produced by
the argon laser. Specifically, the burns from the krypton laser do not involve the inner
retina. Also, the krypton laser spares the nerve fiber layer near the macula. In contrast,
nerve fiber layer burns are common with the argon laser. Pigment epithelium and outer
segments are usually destroyed by both krypton and argon photocoagulation, but there is no
uptake of energy by the vascular tissues within the retina when krypton photocoagulation is
used. Further, krypton treatment is more effective in penetrating nuclear sclerosis of the
lens and can be used to treat some diabetic eyes with this condition that cannot be treated
with the argon laser.

In the KARNS, patients with diabetic retinopathy and NVD of one-third disc area or greater in
extent were assigned at random to either argon or krypton laser scatter photocoagulation
(panretinal photocoagulation). The null hypothesis was that each treatment would result in a
similar proportion of eyes having regression of the NVD by 3 months. The KARNS pilot study
affirmed the benefits of argon laser photocoagulation in the treatment of proliferative
diabetic retinopathy, as demonstrated in the NEI-supported Diabetic Retinopathy Study
conducted a decade ago. (See publication list.) The KARNS study sought to determine whether
use of the krypton laser could be as effective as the argon laser in causing regression of
diabetic neovascularization, but with fewer side effects (such as smaller loss of central
visual acuity).

Thirty-two nationwide clinical centers participated initially in this multicenter clinical
trial. Following the initial study examination, the baseline examination and fundus
photographs were obtained within 1 week before application of photocoagulation. Study
followup visits occurred at 3 months and 1 year after entry in the study. Additional visits
were scheduled as clinically necessary.

The specific techniques for photocoagulation were similar for both argon and krypton scatter
photocoagulation. Scatter (panretinal) photocoagulation consisted of 1,600 to 2,000 burns
placed 0.5 to 1 burn width apart. Burns of moderate intensity (whiteness) and 500 ??m in size
at the retina were required. The burns were applied to the retinal periphery no closer than 2
disc diameters from the center of the fovea and 500 ??m from the margin of the optic disc.

In December 1985, the Early Treatment Diabetic Retinopathy Study groups reported that focal
photocoagulation was effective in reducing the rates of moderate visual loss in patients with
clinically significant diabetic macular edema. The KARNS protocol was then changed to allow
focal treatment for clinically significant macular edema in all study participants and to
allow an eye that had previous focal photocoagulation for macular edema to become eligible
for study.

The study primary end point was regression of NVD, as assessed on the 3-month visit stereo
fundus photographs of the disc, to less than one-third disc area in extent. Secondary end
points included change in extent of NVD, change in visual acuity after photocoagulation,
development of fibrous tissue proliferation, and change or development of macular traction
lines.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1984</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Diabetic Retinopathy</condition>
<condition>Retinal Neovascularization</condition>
<condition>Diabetes Mellitus</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Blue-Green Argon Laser Treatment</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Red Krypton Laser Treatment</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women ages 18 through 79 diagnosed with diabetes mellitus and who had
neovascularization on the optic nerve head (NVD) were eligible. NVD in one or both eyes of
each patient had to be greater than or equal to DRS Standard Photograph 10A. NVD was
defined as new vessels on the surface of the retina, further forward in the vitreous cavity
over the disc, or within one disc diameter of the disc in any direction. Patient's ocular
media must have been clear enough for fundus photography, which allowed the extent of
neovascularization on the optic nerve head to be assessed. (If vitreous hemorrhage or other
media opacity prevented adequate visualization of the neovascularization, it would greatly
impair the ability to assess the effect of photocoagulation.) Another requirement for
patient eligibility was the presence of an area of at least three quadrants of the retina
in which full argon or krypton laser panretinal photocoagulation could be placed. (Vitreous
hemorrhage and/or traction retinal detachment that interfered with treatment was less than
one quadrant in extent.)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>79 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Ferris FL; Ferris FL; Ferris FL; Singerman LJ; Inexpensive collaborative research., Invest Ophthalmol Vis Sci 24 (suppl) 1983</citation>
</reference>
<reference>
<citation>Davis MD; Singerman LJ; Ferris FL III; Passloff RW; Red krypton laser (RKL) versus blue-green argon laser (BGAL) treatment of proliferative diabetic retinopathy (PDR) with neovascularization of the disc (NVD)., Invest Ophthalmol Vis Sci 24 (suppl) 1983</citation>
</reference>
<reference>
<citation>Randomized comparison of krypton versus argon scatter photocoagulation for diabetic disc neovascularization. The Krypton Argon Regression Neovascularization Study report number 1. Ophthalmology. 1993 Nov;100(11):1655-64. doi: 10.1016/s0161-6420(93)31421-1.</citation>
<PMID>8233391</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Diabetic Disc Neovascularization</keyword>
<keyword>Optic Disk</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Diabetic Retinopathy</mesh_term>
<mesh_term>Retinal Neovascularization</mesh_term>
<mesh_term>Neovascularization, Pathologic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000153
org study id: NEI-55
nct id: NCT00000153
lead sponsor:
To evaluate whether red krypton laser treatment is as effective at causing regression of
diabetic disc neovascularization as treatment with the blue-green argon laser, when both
lasers are used with identical panretinal photocoagulation patterns.
To assess the vision of study patients.
To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which
participating clinics are not financially reimbursed and in which both the Coordinating and
Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and
Epidemiology Program.
The KARNS was a randomized clinical trial designed to compare the effectiveness of argon and
krypton laser photocoagulation in causing the regression of preexisting neovascularization on
the disc (NVD) in diabetic retinopathy. The main theoretical advantage for the krypton laser
in the treatment of diabetic retinopathy is that the red laser beam penetrates blood and may
be more effective in making burns in the pigment epithelium in eyes with vitreous hemorrhage.
The burns produced by the krypton laser in the retina are different from those produced by
the argon laser. Specifically, the burns from the krypton laser do not involve the inner
retina. Also, the krypton laser spares the nerve fiber layer near the macula. In contrast,
nerve fiber layer burns are common with the argon laser. Pigment epithelium and outer
segments are usually destroyed by both krypton and argon photocoagulation, but there is no
uptake of energy by the vascular tissues within the retina when krypton photocoagulation is
used. Further, krypton treatment is more effective in penetrating nuclear sclerosis of the
lens and can be used to treat some diabetic eyes with this condition that cannot be treated
with the argon laser.
In the KARNS, patients with diabetic retinopathy and NVD of one-third disc area or greater in
extent were assigned at random to either argon or krypton laser scatter photocoagulation
(panretinal photocoagulation). The null hypothesis was that each treatment would result in a
similar proportion of eyes having regression of the NVD by 3 months. The KARNS pilot study
affirmed the benefits of argon laser photocoagulation in the treatment of proliferative
diabetic retinopathy, as demonstrated in the NEI-supported Diabetic Retinopathy Study
conducted a decade ago. (See publication list.) The KARNS study sought to determine whether
use of the krypton laser could be as effective as the argon laser in causing regression of
diabetic neovascularization, but with fewer side effects (such as smaller loss of central
visual acuity).
Thirty-two nationwide clinical centers participated initially in this multicenter clinical
trial. Following the initial study examination, the baseline examination and fundus
photographs were obtained within 1 week before application of photocoagulation. Study
followup visits occurred at 3 months and 1 year after entry in the study. Additional visits
were scheduled as clinically necessary.
The specific techniques for photocoagulation were similar for both argon and krypton scatter
photocoagulation. Scatter (panretinal) photocoagulation consisted of 1,600 to 2,000 burns
placed 0.5 to 1 burn width apart. Burns of moderate intensity (whiteness) and 500 ??m in size
at the retina were required. The burns were applied to the retinal periphery no closer than 2
disc diameters from the center of the fovea and 500 ??m from the margin of the optic disc.
In December 1985, the Early Treatment Diabetic Retinopathy Study groups reported that focal
photocoagulation was effective in reducing the rates of moderate visual loss in patients with
clinically significant diabetic macular edema. The KARNS protocol was then changed to allow
focal treatment for clinically significant macular edema in all study participants and to
allow an eye that had previous focal photocoagulation for macular edema to become eligible
for study.
The study primary end point was regression of NVD, as assessed on the 3-month visit stereo
fundus photographs of the disc, to less than one-third disc area in extent. Secondary end
points included change in extent of NVD, change in visual acuity after photocoagulation,
development of fibrous tissue proliferation, and change or development of macular traction
lines.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Blue-Green Argon Laser Treatment
intervention type: Procedure
intervention name: Red Krypton Laser Treatment
criteria:
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
citation: Ferris FL; Ferris FL; Ferris FL; Singerman LJ; Inexpensive collaborative research., Invest Ophthalmol Vis Sci 24 (suppl) 1983
citation: Davis MD; Singerman LJ; Ferris FL III; Passloff RW; Red krypton laser (RKL) versus blue-green argon laser (BGAL) treatment of proliferative diabetic retinopathy (PDR) with neovascularization of the disc (NVD)., Invest Ophthalmol Vis Sci 24 (suppl) 1983
citation: Randomized comparison of krypton versus argon scatter photocoagulation for diabetic disc neovascularization. The Krypton Argon Regression Neovascularization Study report number 1. Ophthalmology. 1993 Nov;100(11):1655-64. doi: 10.1016/s0161-6420(93)31421-1.
PMID: 8233391
mesh term: Diabetic Retinopathy
mesh term: Retinal Neovascularization
mesh term: Neovascularization, Pathologic
|
NCT0000xxxx/NCT00000154.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000154</url>
</required_header>
<id_info>
<org_study_id>NEI-56</org_study_id>
<nct_id>NCT00000154</nct_id>
</id_info>
<brief_title>Diabetic Retinopathy Vitrectomy Study (DRVS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare two therapies, early vitrectomy and conventional management, for recent severe
vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes
vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if
retinal detachment involving the center of the macula develops at any time.

To compare early vitrectomy and conventional management in eyes that have good vision but a
poor prognosis because they are threatened with hemorrhage or retinal detachment from very
severe proliferative retinopathy.

To study the natural history of severe proliferative diabetic retinopathy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on
the retina from contraction of the fibrovascular membranes that characterize severe
proliferative diabetic retinopathy. It is important to determine whether early intervention
with vitrectomy has a better visual outcome or instead produces a rate of serious
complications higher than the rate associated with conventional management.

Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had
either insulin-dependent or non-insulin-dependent diabetes. In the first trial, the 616
patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in
at least one eye. Eligible eyes were randomly assigned either to early vitrectomy or to
conventional management. In the conventional management group, vitrectomy was carried out 1
year later if hemorrhage persisted; vitrectomy was carried out sooner if retinal detachment
-involving the center of the macula occurred.

In the second trial, 381 patients were recruited, all of whom had severe fibrovascular
proliferations and useful vision in at least one eye. Eligible eyes were assigned either to
early vitrectomy or to conventional management. Conventional management included
photocoagulation when indicated, with vitrectomy if a severe vitreous hemorrhage occurred and
failed to clear spontaneously during a 6-month waiting period or if retinal detachment
involving the center of the macula -occurred. After randomization and treatment, all patients
were examined at 6-month intervals for 2 years and annually thereafter. Comparisons of visual
acuity distributions between experimental and control groups were made.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>October 1976</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Diabetic Retinopathy</condition>
<condition>Retinal Detachment</condition>
<condition>Vitreous Hemorrhage</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Vitrectomy</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women eligible for the vitreous hemorrhage group had at least one eye with recent
severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients
eligible for the "very severe proliferative retinopathy with useful vision" group had
extensive active fibrovascular proliferations and visual acuity of 10/200 or better.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Two-year course of visual acuity in severe proliferative diabetic retinopathy with conventional management. Diabetic Retinopathy Vitrectomy Study (DRVS) report #1. Ophthalmology. 1985 Apr;92(4):492-502. doi: 10.1016/s0161-6420(85)34002-2.</citation>
<PMID>4000644</PMID>
</reference>
<reference>
<citation>Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. The Diabetic Retinopathy Vitrectomy Study Research Group. Arch Ophthalmol. 1985 Nov;103(11):1644-52.</citation>
<PMID>2865943</PMID>
</reference>
<reference>
<citation>Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 3. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1307-20. doi: 10.1016/s0161-6420(88)33015-0.</citation>
<PMID>2465517</PMID>
</reference>
<reference>
<citation>Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Clinical application of results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 4. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1321-34. doi: 10.1016/s0161-6420(88)33014-9.</citation>
<PMID>2465518</PMID>
</reference>
<reference>
<citation>Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64. doi: 10.1001/archopht.1990.01070090060040. Erratum In: Arch Ophthalmol 1990 Oct;108(10):1452.</citation>
<PMID>2196036</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Diabetic Retinopathy</mesh_term>
<mesh_term>Retinal Detachment</mesh_term>
<mesh_term>Vitreous Hemorrhage</mesh_term>
<mesh_term>Hemorrhage</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000154
org study id: NEI-56
nct id: NCT00000154
lead sponsor:
To compare two therapies, early vitrectomy and conventional management, for recent severe
vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes
vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if
retinal detachment involving the center of the macula develops at any time.
To compare early vitrectomy and conventional management in eyes that have good vision but a
poor prognosis because they are threatened with hemorrhage or retinal detachment from very
severe proliferative retinopathy.
To study the natural history of severe proliferative diabetic retinopathy.
Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on
the retina from contraction of the fibrovascular membranes that characterize severe
proliferative diabetic retinopathy. It is important to determine whether early intervention
with vitrectomy has a better visual outcome or instead produces a rate of serious
complications higher than the rate associated with conventional management.
Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had
either insulin-dependent or non-insulin-dependent diabetes. In the first trial, the 616
patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in
at least one eye. Eligible eyes were randomly assigned either to early vitrectomy or to
conventional management. In the conventional management group, vitrectomy was carried out 1
year later if hemorrhage persisted; vitrectomy was carried out sooner if retinal detachment
-involving the center of the macula occurred.
In the second trial, 381 patients were recruited, all of whom had severe fibrovascular
proliferations and useful vision in at least one eye. Eligible eyes were assigned either to
early vitrectomy or to conventional management. Conventional management included
photocoagulation when indicated, with vitrectomy if a severe vitreous hemorrhage occurred and
failed to clear spontaneously during a 6-month waiting period or if retinal detachment
involving the center of the macula -occurred. After randomization and treatment, all patients
were examined at 6-month intervals for 2 years and annually thereafter. Comparisons of visual
acuity distributions between experimental and control groups were made.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Vitrectomy
criteria:
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
citation: Two-year course of visual acuity in severe proliferative diabetic retinopathy with conventional management. Diabetic Retinopathy Vitrectomy Study (DRVS) report #1. Ophthalmology. 1985 Apr;92(4):492-502. doi: 10.1016/s0161-6420(85)34002-2.
PMID: 4000644
citation: Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. The Diabetic Retinopathy Vitrectomy Study Research Group. Arch Ophthalmol. 1985 Nov;103(11):1644-52.
PMID: 2865943
citation: Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 3. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1307-20. doi: 10.1016/s0161-6420(88)33015-0.
PMID: 2465517
citation: Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Clinical application of results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 4. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1321-34. doi: 10.1016/s0161-6420(88)33014-9.
PMID: 2465518
citation: Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64. doi: 10.1001/archopht.1990.01070090060040. Erratum In: Arch Ophthalmol 1990 Oct;108(10):1452.
PMID: 2196036
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Retinal Detachment
mesh term: Vitreous Hemorrhage
mesh term: Hemorrhage
|
NCT0000xxxx/NCT00000155.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000155</url>
</required_header>
<id_info>
<org_study_id>NEI-57</org_study_id>
<nct_id>NCT00000155</nct_id>
</id_info>
<brief_title>The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To describe the clinical course of keratoconus and to describe the relationships among its
visual and physiological manifestations, including high- and low-contrast visual acuity,
corneal curvature, slit lamp biomicroscopic findings, corneal scarring, and quality of life.

To identify risk factors and protective factors that influence the severity and progression
of keratoconus.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Keratoconus is a bilateral, asymmetric, chronic, progressive ectasia of the cornea
characterized by steepening and distortion of the cornea, thinning of the apical cornea,
corneal scarring, and treatment-related sequelae, such as abrasions from contact lenses and
surgical complications. Patients experience distorted vision that worsens with disease
progression. Their vision is typically corrected with spectacles early in the disease and,
later, with rigid contact lenses. Some patients eventually undergo corneal transplantation in
one or both eyes. Keratoconus affects people in their prime earning years and profoundly
affects their lives.

Previous large-scale studies of keratoconus have focused on incidence and prevalence,
etiologies, or the clinical management of keratoconus. Few have characterized the course of
the disease and risk factors for its progression in large samples of keratoconus patients.
The incidence of vision-threatening corneal scarring in keratoconus is unknown. Patient's
most frequent questions--how rapidly their keratoconus will progress, how bad their vision
will become, whether they will need corneal surgery, how successful their contact lenses will
be--cannot be answered on the basis of the current body of knowledge.

The need for a prospective, observational study of keratoconus patients is great. Results
from this study will address keratoconus patient's unanswered questions and will enable eye
care practitioners to manage this complex ocular disease better.

The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a multicenter,
observational study of 1,209 keratoconus patients followed for 3 years.

Patients are examined annually. Study measures include visual acuity, patient-reported
quality of life, manifest refraction, keratometry, photodocumentation of the cornea to
identify central corneal scarring, photodocumentation of the flattest contact lens that just
clears the cornea, slit lamp biomicroscopy, and corneal topography. In rigid contact lens
wearers, the fluorescein pattern of the patient's habitual contact lenses is photodocumented.

Patients are examined at 15 clinical centers. The clinical centers enrolled 1,209 patients in
12 months.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>June 1995</start_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<condition>Keratoconus</condition>
<eligibility>
<criteria>
<textblock>
Patients with keratoconus were eligible if they were at least 12 years old; had an
irregular cornea as determined by keratometry, retinoscopy, or direct ophthalmoscopy in at
least one eye; had Vogt's striae, Fleischer's ring, or corneal scarring characteristic of
keratoconus in at least one eye; and planned to stay in the area for at least 3 years. They
were ineligible if they had bilateral corneal transplants or bilateral nonkeratoconic eye
disease (cataract, intraocular lenses, macular disease, or optic nerve disease other than
glaucoma).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>12 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of California, Berkeley, School of Optometry</name>
<address>
<city>Berkeley</city>
<state>California</state>
<zip>94720-2020</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southern California College of Optometry</name>
<address>
<city>Fullerton</city>
<state>California</state>
<zip>92831</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jules Stein Eye Institute, University of California at Los Angeles</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095-7003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Nova Southeastern University, Health Professions Division, College of Optometry</name>
<address>
<city>Ft. Lauderdale</city>
<state>Florida</state>
<zip>33328</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Illinois at Chicago, Department of Ophthalmology and Visual Sciences</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60612</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University, School of Optometry</name>
<address>
<city>Bloomington</city>
<state>Indiana</state>
<zip>47405-3680</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Missouri-St. Louis, School of Optometry</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63121</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY State College of Optometry</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10036-8003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Hospitals of Cleveland, Department of Ophthalmology</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44106</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Ohio State University, College of Optometry</name>
<address>
<city>Columbus</city>
<state>Ohio</state>
<zip>43210-1240</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pennsylvania College of Optometry, The Eye Institute</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19141</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Northeastern Eye Institute</name>
<address>
<city>Scranton</city>
<state>Pennsylvania</state>
<zip>18503</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Utah, John Moran Eye Center</name>
<address>
<city>Salt Lake City</city>
<state>Utah</state>
<zip>84132</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Gundersen Lutheran</name>
<address>
<city>La Crosse</city>
<state>Wisconsin</state>
<zip>54601</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Barr JT, Gordon MO, Zadnik K, Pellican K, Edrington TB. Photodocumentation of corneal scarring. Collaborative Longitudinal Evaluation of Keratoconus Study Group. J Refract Surg. 1996 May-Jun;12(4):492-500. doi: 10.3928/1081-597X-19960501-13.</citation>
<PMID>8771545</PMID>
</reference>
<reference>
<citation>Edrington TB, Barr JT, Zadnik K, Davis LJ, Gundel RE, Libassi DP, McMahon TT, Gordon MO. Standardized rigid contact lens fitting protocol for keratoconus. Optom Vis Sci. 1996 Jun;73(6):369-75. doi: 10.1097/00006324-199606000-00003.</citation>
<PMID>8807647</PMID>
</reference>
<reference>
<citation>Gundel RE, Libassi DP, Zadnik K, Barr JT, Davis L, McMahon TT, Edrington TB, Gordon MO. Feasibility of fitting contact lenses with apical clearance in keratoconus. Optom Vis Sci. 1996 Dec;73(12):729-32. doi: 10.1097/00006324-199612000-00002.</citation>
<PMID>9002088</PMID>
</reference>
<reference>
<citation>Zadnik K, Barr JT, Gordon MO, Edrington TB. Biomicroscopic signs and disease severity in keratoconus. Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study Group. Cornea. 1996 Mar;15(2):139-46. doi: 10.1097/00003226-199603000-00006.</citation>
<PMID>8925661</PMID>
</reference>
<verification_date>November 2001</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Keratoconus</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000155
org study id: NEI-57
nct id: NCT00000155
lead sponsor:
To describe the clinical course of keratoconus and to describe the relationships among its
visual and physiological manifestations, including high- and low-contrast visual acuity,
corneal curvature, slit lamp biomicroscopic findings, corneal scarring, and quality of life.
To identify risk factors and protective factors that influence the severity and progression
of keratoconus.
Keratoconus is a bilateral, asymmetric, chronic, progressive ectasia of the cornea
characterized by steepening and distortion of the cornea, thinning of the apical cornea,
corneal scarring, and treatment-related sequelae, such as abrasions from contact lenses and
surgical complications. Patients experience distorted vision that worsens with disease
progression. Their vision is typically corrected with spectacles early in the disease and,
later, with rigid contact lenses. Some patients eventually undergo corneal transplantation in
one or both eyes. Keratoconus affects people in their prime earning years and profoundly
affects their lives.
Previous large-scale studies of keratoconus have focused on incidence and prevalence,
etiologies, or the clinical management of keratoconus. Few have characterized the course of
the disease and risk factors for its progression in large samples of keratoconus patients.
The incidence of vision-threatening corneal scarring in keratoconus is unknown. Patient's
most frequent questions--how rapidly their keratoconus will progress, how bad their vision
will become, whether they will need corneal surgery, how successful their contact lenses will
be--cannot be answered on the basis of the current body of knowledge.
The need for a prospective, observational study of keratoconus patients is great. Results
from this study will address keratoconus patient's unanswered questions and will enable eye
care practitioners to manage this complex ocular disease better.
The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a multicenter,
observational study of 1,209 keratoconus patients followed for 3 years.
Patients are examined annually. Study measures include visual acuity, patient-reported
quality of life, manifest refraction, keratometry, photodocumentation of the cornea to
identify central corneal scarring, photodocumentation of the flattest contact lens that just
clears the cornea, slit lamp biomicroscopy, and corneal topography. In rigid contact lens
wearers, the fluorescein pattern of the patient's habitual contact lenses is photodocumented.
Patients are examined at 15 clinical centers. The clinical centers enrolled 1,209 patients in
12 months.
time perspective: Prospective
criteria:
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
citation: Barr JT, Gordon MO, Zadnik K, Pellican K, Edrington TB. Photodocumentation of corneal scarring. Collaborative Longitudinal Evaluation of Keratoconus Study Group. J Refract Surg. 1996 May-Jun;12(4):492-500. doi: 10.3928/1081-597X-19960501-13.
PMID: 8771545
citation: Edrington TB, Barr JT, Zadnik K, Davis LJ, Gundel RE, Libassi DP, McMahon TT, Gordon MO. Standardized rigid contact lens fitting protocol for keratoconus. Optom Vis Sci. 1996 Jun;73(6):369-75. doi: 10.1097/00006324-199606000-00003.
PMID: 8807647
citation: Gundel RE, Libassi DP, Zadnik K, Barr JT, Davis L, McMahon TT, Edrington TB, Gordon MO. Feasibility of fitting contact lenses with apical clearance in keratoconus. Optom Vis Sci. 1996 Dec;73(12):729-32. doi: 10.1097/00006324-199612000-00002.
PMID: 9002088
citation: Zadnik K, Barr JT, Gordon MO, Edrington TB. Biomicroscopic signs and disease severity in keratoconus. Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study Group. Cornea. 1996 Mar;15(2):139-46. doi: 10.1097/00003226-199603000-00006.
PMID: 8925661
mesh term: Keratoconus
|
NCT0000xxxx/NCT00000156.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000156</url>
</required_header>
<id_info>
<org_study_id>NEI-58</org_study_id>
<nct_id>NCT00000156</nct_id>
</id_info>
<brief_title>The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate the effect of ambient light reduction on the incidence of retinopathy of
prematurity (ROP).
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Despite progress during the past decade in treatment of ROP, this disease still poses a
significant (approximately 2.1 percent) risk of blindness to extremely low birth-weight
(<1,251 grams) preterm infants. Current estimates indicate that about 27,000 infants of
extremely low birth weight are born annually, of which 74 percent will survive. As techniques
of managing smaller and less mature preterm infants continue to improve, it is expected that
the number of infants at risk for blindness will continue to increase.

For infants weighing less than 1,251 grams at birth, the Cryotherapy for Retinopathy of
Prematurity (CRYO-ROP) Study has shown that the risk of developing severe, acute (threshold)
ROP is 6 percent. Although cryotherapy, when applied at the time of threshold ROP, reduces
the rate of unfavorable visual outcome, 35 percent of eyes that develop this level of severe,
acute disease are blind 1 year after treatment. Moreover, cryotherapy is destructive. Even
when cryotherapy prevents progression to retinal detachment, it is associated with peripheral
retinal destruction and may, in some cases, be associated with subnormal central vision due
to high myopia and/or macular scarring. Corrective surgical treatments for retinal detachment
caused by ROP have proven to be of little visual benefit. A preventive treatment for ROP that
is safe, efficacious, easily applied, and inexpensive is desirable.

The investigators hypothesize that reducing the amount of light that reaches the eyes of
preterm infants may be effective in preventing ROP. Although previous reports on the use of
light reduction to the eyes of preterm infants in the nursery have produced conflicting
results, there are sufficient reasons to believe that this strategy may be effective in
reducing the incidence and severity of ROP. These reasons center on the role of light in the
production of destructive free radicals. Supplemental oxygen produces the same free radicals,
and the two mechanisms may be additive.

In this masked, controlled study, infants weighing less than 1,251 grams at birth were
prospectively randomized within 24 hours of birth to wear goggles or not to wear goggles.
Goggles contain 97 percent near neutral density filters and were worn until the infant
reached either 31 weeks gestational age or 4 weeks postnatal age, whichever was longer. The
goggled and nongoggled infants were exposed to the same ambient light conditions within any
given Study Center. Eyes of all infants were examined on a prescribed schedule by certified
examiners to determine the incidence of any confirmed ROP.

The primary objective of this study is to answer the following question: Does light reduction
to the eyes of extremely low birth-weight infants decrease the incidence of any confirmed ROP
(at least 3 contiguous clock hours, any stage, any zone)? The primary end points are
therefore ROP or full vascularization.

The secondary objective of this study is to evaluate the following question: Does light
reduction to the eyes of extremely low birth-weight infants decrease the incidence of more
severe ROP (prethreshold ROP -- the secondary end point)?

The study has recruited approximately 400 infants, equally divided into goggle-wearing and
control group. Since randomization must occur within 24 hours of birth, the investigators
anticipate a mortality rate of between 10 percent and 20 percent of enrollees prior to
outcome. The study is in the followup phase with regular ophthalmologic exams until either
ROP regression or normal full retinal vascularization is established. A final exam occurs at
adjusted age 6 months.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>July 1995</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Retinopathy of Prematurity</condition>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Goggles</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Ambient Light Reduction</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Premature infants weighing less than 1,251 grams at birth and having a gestational age of
less than 31 weeks were eligible for randomization. Consent must have been obtained within
24 hours of birth. Patients with major congenital anomalies are excluded.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>1 Day</maximum_age>
</eligibility>
<location>
<facility>
<name>The Children's Hospital of Buffalo</name>
<address>
<city>Buffalo</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The University of Texas, Southwestern Medical Center at Dallas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas, Health Science Center, San Antonio</name>
<address>
<city>San Antonio</city>
<state>Texas</state>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/lightpr.asp</url>
<description>NEI Press Release-Light Reduction Does Not Affect Blinding Eye Disease in Premature Infants</description>
</link>
<reference>
<citation>Reynolds JD, Hardy RJ, Kennedy KA, Spencer R, van Heuven WA, Fielder AR. Lack of efficacy of light reduction in preventing retinopathy of prematurity. Light Reduction in Retinopathy of Prematurity (LIGHT-ROP) Cooperative Group. N Engl J Med. 1998 May 28;338(22):1572-6. doi: 10.1056/NEJM199805283382202.</citation>
<PMID>9603794</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 2, 2006</last_update_submitted>
<last_update_submitted_qc>June 2, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 5, 2006</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Retinopathy of Prematurity</mesh_term>
<mesh_term>Premature Birth</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000156
org study id: NEI-58
nct id: NCT00000156
lead sponsor:
To evaluate the effect of ambient light reduction on the incidence of retinopathy of
prematurity (ROP).
Despite progress during the past decade in treatment of ROP, this disease still poses a
significant (approximately 2.1 percent) risk of blindness to extremely low birth-weight
(<1,251 grams) preterm infants. Current estimates indicate that about 27,000 infants of
extremely low birth weight are born annually, of which 74 percent will survive. As techniques
of managing smaller and less mature preterm infants continue to improve, it is expected that
the number of infants at risk for blindness will continue to increase.
For infants weighing less than 1,251 grams at birth, the Cryotherapy for Retinopathy of
Prematurity (CRYO-ROP) Study has shown that the risk of developing severe, acute (threshold)
ROP is 6 percent. Although cryotherapy, when applied at the time of threshold ROP, reduces
the rate of unfavorable visual outcome, 35 percent of eyes that develop this level of severe,
acute disease are blind 1 year after treatment. Moreover, cryotherapy is destructive. Even
when cryotherapy prevents progression to retinal detachment, it is associated with peripheral
retinal destruction and may, in some cases, be associated with subnormal central vision due
to high myopia and/or macular scarring. Corrective surgical treatments for retinal detachment
caused by ROP have proven to be of little visual benefit. A preventive treatment for ROP that
is safe, efficacious, easily applied, and inexpensive is desirable.
The investigators hypothesize that reducing the amount of light that reaches the eyes of
preterm infants may be effective in preventing ROP. Although previous reports on the use of
light reduction to the eyes of preterm infants in the nursery have produced conflicting
results, there are sufficient reasons to believe that this strategy may be effective in
reducing the incidence and severity of ROP. These reasons center on the role of light in the
production of destructive free radicals. Supplemental oxygen produces the same free radicals,
and the two mechanisms may be additive.
In this masked, controlled study, infants weighing less than 1,251 grams at birth were
prospectively randomized within 24 hours of birth to wear goggles or not to wear goggles.
Goggles contain 97 percent near neutral density filters and were worn until the infant
reached either 31 weeks gestational age or 4 weeks postnatal age, whichever was longer. The
goggled and nongoggled infants were exposed to the same ambient light conditions within any
given Study Center. Eyes of all infants were examined on a prescribed schedule by certified
examiners to determine the incidence of any confirmed ROP.
The primary objective of this study is to answer the following question: Does light reduction
to the eyes of extremely low birth-weight infants decrease the incidence of any confirmed ROP
(at least 3 contiguous clock hours, any stage, any zone)? The primary end points are
therefore ROP or full vascularization.
The secondary objective of this study is to evaluate the following question: Does light
reduction to the eyes of extremely low birth-weight infants decrease the incidence of more
severe ROP (prethreshold ROP -- the secondary end point)?
The study has recruited approximately 400 infants, equally divided into goggle-wearing and
control group. Since randomization must occur within 24 hours of birth, the investigators
anticipate a mortality rate of between 10 percent and 20 percent of enrollees prior to
outcome. The study is in the followup phase with regular ophthalmologic exams until either
ROP regression or normal full retinal vascularization is established. A final exam occurs at
adjusted age 6 months.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Device
intervention name: Goggles
intervention type: Procedure
intervention name: Ambient Light Reduction
criteria:
gender: All
minimum age: N/A
maximum age: 1 Day
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/news/pressreleases/lightpr.asp
description: NEI Press Release-Light Reduction Does Not Affect Blinding Eye Disease in Premature Infants
citation: Reynolds JD, Hardy RJ, Kennedy KA, Spencer R, van Heuven WA, Fielder AR. Lack of efficacy of light reduction in preventing retinopathy of prematurity. Light Reduction in Retinopathy of Prematurity (LIGHT-ROP) Cooperative Group. N Engl J Med. 1998 May 28;338(22):1572-6. doi: 10.1056/NEJM199805283382202.
PMID: 9603794
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
|
NCT0000xxxx/NCT00000157.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000157</url>
</required_header>
<id_info>
<org_study_id>NEI-59</org_study_id>
<nct_id>NCT00000157</nct_id>
</id_info>
<brief_title>Randomized Trial of Aspirin and Cataracts in U.S. Physicians</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of
developing cataract among male U.S. physicians who were aged 40 to 84 in 1982.

To identify potential risk factors for cataract development, such as age, blood pressure,
blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or
surgery.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Cataract is one of the most common causes of impaired vision as well as the third leading
cause of blindness in the United States. Cataract surgery is one of the safest and most
successful of all operations. The National Eye Institute has estimated that if the
progression of cataract could be slowed enough to delay the need for surgery by even 10
years, the current annual number could be reduced by 45 percent.

Little is known about the relative importance of various potential risk factors in the
development of cataract. Most current information on risk factors has come from anecdotal
reports or from relatively small case-control studies. One major project, the Framingham Eye
Study, has identified several factors that were significantly associated with subsequent
cataract formation, including diabetes and dietary factors. Diabetes has long been thought to
increase the risk of developing cataract.

Recently, aspirin has been proposed as a drug that can prevent cataract formation or slow its
progression. Aspirin may affect tryptophan levels in patients with cataract, or it may
inhibit aldose reductase, an enzyme associated with the development of diabetic cataract.
Thus, data from this study sought to determine whether one 325-mg aspirin tablet, taken on
alternate days, protects against cataract formation. The data also sought to reveal other
additional cataract risk factors that emerge after simultaneous controlling for other
variables.

The other primary objective of this trial was to assess the antioxidant effects of
beta-carotene (50 mg on alternate days) on cataract development. In addition, factors that
have been suggested to be cataractogenic were assessed in prospective cohort studies. These
factors included age, blood pressure, blood cholesterol, height, diabetes, medication use,
cigarette smoking, and history of previous eye trauma or surgery. In addition, the possible
associations between history of vitamin E and selenium intake and cataract were explored.

This trial was part of the Physicians Health Study, an ongoing, randomized,
placebo-controlled clinical trial of aspirin in the prevention of cardiovascular mortality
and of beta-carotene in the prevention of cancer. Following randomization, each of the 22,071
physicians enrolled was assigned to one of four groups to take either aspirin or its placebo
and beta-carotene or its placebo. Follow-up questionnaires were sent 6 and 12 months after
randomization and every 12 months thereafter. The randomized aspirin component of the trial
was terminated early (January 1988), after an average followup of approximately 5 years,
because of a statistically extreme 44 percent reduced risk of a first myocardial infarction
in the aspirin group.

Since this study is conducted by mail among physicians nationwide, examinations cannot be
performed on all patients to determine when they have reached an end point. Reported
diagnoses of cataract are confirmed by medical record review. The primary analysis will be of
incidence of cataract in the aspirin and placebo groups. In addition, the Cox proportional
hazards model will be used to determine whether there is a difference in time to cataract
diagnosis between the two groups. It has been postulated that the potent antioxidant
properties of beta-carotene might make it effective in preventing cataract development. The
investigators will thus determine whether there is a difference in the numbers of cataracts
between the beta-carotene/placebo groups and the aspirin/placebo groups.
</textblock>
</detailed_description>
<overall_status>Terminated</overall_status>
<start_date>April 1982</start_date>
<completion_date type="Actual">January 1988</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Prevention</primary_purpose>
</study_design_info>
<condition>Cataract</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aspirin</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
The study population consisted of 22,071 male U.S. physicians, aged 40 to 84 years in 1982,
with no history of myocardial infarction, cancer, kidney disease, renal disease, or any
other contraindication to the use of aspirin or beta-carotene, including regular use of
corticosteroids.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>40 Years</minimum_age>
<maximum_age>84 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<reference>
<citation>Seddon JM, Christen WG, Manson JE, Buring JE, Sperduto RD, Hennekens CH. Low-dose aspirin and risks of cataract in a randomized trial of US physicians. Arch Ophthalmol. 1991 Feb;109(2):252-5. doi: 10.1001/archopht.1991.01080020098052.</citation>
<PMID>1993037</PMID>
</reference>
<reference>
<citation>Christen WG, Manson JE, Seddon JM, Glynn RJ, Buring JE, Rosner B, Hennekens CH. A prospective study of cigarette smoking and risk of cataract in men. JAMA. 1992 Aug 26;268(8):989-93.</citation>
<PMID>1501324</PMID>
</reference>
<reference>
<citation>Christen WG, Glynn RJ, Seddon JM, Manson JE, Buring JE, Hennekens CH. Confirmation of self-reported cataract in the Physicians' Health Study. Ophthalmic Epidemiol. 1994 Jun;1(2):85-91. doi: 10.3109/09286589409052364.</citation>
<PMID>8790615</PMID>
</reference>
<reference>
<citation>Manson JE, Christen WG, Seddon JM, Glynn RJ, Hennekens CH. A prospective study of alcohol consumption and risk of cataract. Am J Prev Med. 1994 May-Jun;10(3):156-61.</citation>
<PMID>7917442</PMID>
</reference>
<reference>
<citation>Seddon JM, Christen WG, Manson JE, LaMotte FS, Glynn RJ, Buring JE, Hennekens CH. The use of vitamin supplements and the risk of cataract among US male physicians. Am J Public Health. 1994 May;84(5):788-92. doi: 10.2105/ajph.84.5.788.</citation>
<PMID>8179050</PMID>
</reference>
<reference>
<citation>Glynn RJ, Christen WG, Manson JE, Bernheimer J, Hennekens CH. Body mass index. An independent predictor of cataract. Arch Ophthalmol. 1995 Sep;113(9):1131-7. doi: 10.1001/archopht.1995.01100090057023.</citation>
<PMID>7661746</PMID>
</reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cataract</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aspirin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000157
org study id: NEI-59
nct id: NCT00000157
lead sponsor:
To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of
developing cataract among male U.S. physicians who were aged 40 to 84 in 1982.
To identify potential risk factors for cataract development, such as age, blood pressure,
blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or
surgery.
Cataract is one of the most common causes of impaired vision as well as the third leading
cause of blindness in the United States. Cataract surgery is one of the safest and most
successful of all operations. The National Eye Institute has estimated that if the
progression of cataract could be slowed enough to delay the need for surgery by even 10
years, the current annual number could be reduced by 45 percent.
Little is known about the relative importance of various potential risk factors in the
development of cataract. Most current information on risk factors has come from anecdotal
reports or from relatively small case-control studies. One major project, the Framingham Eye
Study, has identified several factors that were significantly associated with subsequent
cataract formation, including diabetes and dietary factors. Diabetes has long been thought to
increase the risk of developing cataract.
Recently, aspirin has been proposed as a drug that can prevent cataract formation or slow its
progression. Aspirin may affect tryptophan levels in patients with cataract, or it may
inhibit aldose reductase, an enzyme associated with the development of diabetic cataract.
Thus, data from this study sought to determine whether one 325-mg aspirin tablet, taken on
alternate days, protects against cataract formation. The data also sought to reveal other
additional cataract risk factors that emerge after simultaneous controlling for other
variables.
The other primary objective of this trial was to assess the antioxidant effects of
beta-carotene (50 mg on alternate days) on cataract development. In addition, factors that
have been suggested to be cataractogenic were assessed in prospective cohort studies. These
factors included age, blood pressure, blood cholesterol, height, diabetes, medication use,
cigarette smoking, and history of previous eye trauma or surgery. In addition, the possible
associations between history of vitamin E and selenium intake and cataract were explored.
This trial was part of the Physicians Health Study, an ongoing, randomized,
placebo-controlled clinical trial of aspirin in the prevention of cardiovascular mortality
and of beta-carotene in the prevention of cancer. Following randomization, each of the 22,071
physicians enrolled was assigned to one of four groups to take either aspirin or its placebo
and beta-carotene or its placebo. Follow-up questionnaires were sent 6 and 12 months after
randomization and every 12 months thereafter. The randomized aspirin component of the trial
was terminated early (January 1988), after an average followup of approximately 5 years,
because of a statistically extreme 44 percent reduced risk of a first myocardial infarction
in the aspirin group.
Since this study is conducted by mail among physicians nationwide, examinations cannot be
performed on all patients to determine when they have reached an end point. Reported
diagnoses of cataract are confirmed by medical record review. The primary analysis will be of
incidence of cataract in the aspirin and placebo groups. In addition, the Cox proportional
hazards model will be used to determine whether there is a difference in time to cataract
diagnosis between the two groups. It has been postulated that the potent antioxidant
properties of beta-carotene might make it effective in preventing cataract development. The
investigators will thus determine whether there is a difference in the numbers of cataracts
between the beta-carotene/placebo groups and the aspirin/placebo groups.
allocation: Randomized
primary purpose: Prevention
intervention type: Drug
intervention name: Aspirin
criteria:
gender: Male
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Seddon JM, Christen WG, Manson JE, Buring JE, Sperduto RD, Hennekens CH. Low-dose aspirin and risks of cataract in a randomized trial of US physicians. Arch Ophthalmol. 1991 Feb;109(2):252-5. doi: 10.1001/archopht.1991.01080020098052.
PMID: 1993037
citation: Christen WG, Manson JE, Seddon JM, Glynn RJ, Buring JE, Rosner B, Hennekens CH. A prospective study of cigarette smoking and risk of cataract in men. JAMA. 1992 Aug 26;268(8):989-93.
PMID: 1501324
citation: Christen WG, Glynn RJ, Seddon JM, Manson JE, Buring JE, Hennekens CH. Confirmation of self-reported cataract in the Physicians' Health Study. Ophthalmic Epidemiol. 1994 Jun;1(2):85-91. doi: 10.3109/09286589409052364.
PMID: 8790615
citation: Manson JE, Christen WG, Seddon JM, Glynn RJ, Hennekens CH. A prospective study of alcohol consumption and risk of cataract. Am J Prev Med. 1994 May-Jun;10(3):156-61.
PMID: 7917442
citation: Seddon JM, Christen WG, Manson JE, LaMotte FS, Glynn RJ, Buring JE, Hennekens CH. The use of vitamin supplements and the risk of cataract among US male physicians. Am J Public Health. 1994 May;84(5):788-92. doi: 10.2105/ajph.84.5.788.
PMID: 8179050
citation: Glynn RJ, Christen WG, Manson JE, Bernheimer J, Hennekens CH. Body mass index. An independent predictor of cataract. Arch Ophthalmol. 1995 Sep;113(9):1131-7. doi: 10.1001/archopht.1995.01100090057023.
PMID: 7661746
mesh term: Cataract
mesh term: Aspirin
|
NCT0000xxxx/NCT00000158.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000158</url>
</required_header>
<id_info>
<org_study_id>NEI-60</org_study_id>
<nct_id>NCT00000158</nct_id>
</id_info>
<brief_title>Macular Photocoagulation Study (MPS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate laser treatment of choroidal neovascularization (CNV) through randomized,
controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets
of randomized, controlled clinical trials. Change in best-corrected visual acuity from
baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated
in each set of trials. The purpose of each is described below.

Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal
blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from
the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss
of central vision in patients with age-related (senile) macular degeneration (AMD), presumed
ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial
was conducted for each of the three underlying conditions.

Krypton Study: To determine whether krypton red laser photocoagulation of choroidal
neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is
of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH,
and INVM. A separate trial was conducted for each of the three underlying conditions.

Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or
delaying further visual acuity loss in patients with new (never treated) or recurrent
(previously treated with laser photocoagulation) choroidal neovascularization under the
center of the FAZ. Two separate trials, one for each type of lesion, were carried out.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In each randomized trial conducted by the MPS Group, focal laser photocoagulation was
compared to observation without treatment. Patients were assigned to laser treatment or to
observation with equal probability. The first set of MPS randomized trials, the Argon Study,
focused on the effectiveness of photocoagulation with argon blue-green laser in eyes with
discrete extrafoveal choroidal neovascularization. The study investigators, who began
recruiting patients in 1979, estimated that 550 patients with AMD and 750 with POH would be
required. Follow-up was to continue for 5 years to determine whether argon laser
photocoagulation treatment could prevent or delay visual acuity loss in these patients.

After the initiation of the Argon Study, a new krypton red laser became available. The new
wavelength offered theoretical advantages over the argon laser for treating CNV that extended
inside the FAZ of the macula. The Krypton Study design was analogous to the Argon Study, with
the investigation of three underlying conditions, except that CNV was closer to the FAZ
center.

The third set of MPS clinical trials, the Foveal Study, was designed to determine whether
laser photocoagulation was effective for delaying or preventing further visual acuity loss in
AMD patients who have subfoveal CNV. Among patients assigned to laser treatment in the Foveal
Study, argon laser treatment was compared with krypton red laser treatment of these lesions.
The investigators originally projected that about 350 patients would be required for each
clinical trial of the Foveal Study.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>February 1979</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Choroidal Neovascularization</condition>
<condition>Macular Degeneration</condition>
<condition>Histoplasmosis</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Blue-Green Laser Photocoagulation</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Common Eligibility Criteria for the Argon, Krypton, and Foveal Studies:

To be eligible, men and women must have been experiencing visual symptoms attributable to
the macular lesion, such as decreased visual acuity or Amsler grid distortion, at the time
of entry into the study. They also must have had visible, well-demarcated hyperfluorescence
characteristic of classic choroidal neovascularization on fluorescein angiography. AMD
patients were 50 years of age or older and had drusen visible in the macula of at least one
eye. POH patients were at least 18 years old and had at least one characteristic histo spot
in one or both eyes. INVM patients were at least 18 years old and had no evidence of AMD,
POH, angioid streaks, high myopia, diabetic retinopathy, or any other condition that could
be the cause of the neovascularization. In particular, INVM patients had neither drusen
greater than MPS Standard Photograph No. 1.1 nor histo spots in either eye.

Additional Patient Eligibility Criteria for the Argon Study:

Each patient had a visible serous detachment of the sensory retina with a diffuse area of
leakage, discrete choroidal neovascularization outside the fovea (200-2,500 microns from
the center of the FAZ), and visual acuity of 20/100 or better in the study eye.

Additional Patient Eligibility Criteria for the Krypton Study:

All patients had a neovascular lesion consisting of neovascularization and possibly blood
and/or pigment that extended into the FAZ. The posterior border of CNV could extend as
close as 1 micron to the FAZ center. Visual acuity of the study eye was 20/400 or better.

Additional Patient Eligibility Criteria for the Foveal Study:

Only patients with AMD were eligible for this study. Fluorescein angiography of the
eligible eye had to show evidence of a leaking choroidal neovascular membrane, some part of
which extended under the center of the FAZ, or a neovascular lesion consisting of an old
laser treatment scar and contiguous leaking neovascularization within 150 microns of the
center of the FAZ. New, never-treated subfoveal lesions were less than four disc areas in
size. Recurrent lesions were less than six disc areas in size, including the old treatment
scar and new neovascularization. Best-corrected visual acuity was no better than 20/40 and
no worse than 20/320.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Changing the protocol: a case report from the Macular Photocoagulation Study. Macular Photocoagulation Study Group. Control Clin Trials. 1984 Sep;5(3):203-16. doi: 10.1016/0197-2456(84)90024-2.</citation>
<PMID>6488805</PMID>
</reference>
<reference>
<citation>Hillis A, Maguire M, Hawkins BS, Newhouse MM. The Markov process as a general method for nonparametric analysis of right-censored medical data. J Chronic Dis. 1986;39(8):595-604. doi: 10.1016/0021-9681(86)90184-0.</citation>
<PMID>3525597</PMID>
</reference>
<reference>
<citation>Blackhurst DW, Maguire MG. Reproducibility of refraction and visual acuity measurement under a standard protocol. The Macular Photocoagulation Study Group. Retina. 1989;9(3):163-9.</citation>
<PMID>2480626</PMID>
</reference>
<reference>
<citation>Hawkins BS, Prior MJ, Fisher MR, Blackhurst DW. Relationship between rate of patient enrollment and quality of clinical center performance in two multicenter trials in ophthalmology. Control Clin Trials. 1990 Oct;11(5):374-94. doi: 10.1016/0197-2456(90)90177-4.</citation>
<PMID>1963130</PMID>
</reference>
<reference>
<citation>Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol. 1982 Jun;100(6):912-8. doi: 10.1001/archopht.1982.01030030920003.</citation>
<PMID>7046707</PMID>
</reference>
<reference>
<citation>Argon laser photocoagulation for ocular histoplasmosis. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1347-57. doi: 10.1001/archopht.1983.01040020349002.</citation>
<PMID>6193771</PMID>
</reference>
<reference>
<citation>Argon laser photocoagulation for idiopathic neovascularization. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1358-61. doi: 10.1001/archopht.1983.01040020360003.</citation>
<PMID>6193772</PMID>
</reference>
<reference>
<citation>Fine SL. Early detection of extrafoveal neovascular membranes by daily central field evaluation. Ophthalmology. 1985 May;92(5):603-9. doi: 10.1016/s0161-6420(85)33995-7.</citation>
<PMID>2409502</PMID>
</reference>
<reference>
<citation>Recurrent choroidal neovascularization after argon laser photocoagulation for neovascular maculopathy. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 Apr;104(4):503-12. doi: 10.1001/archopht.1986.01050160059012.</citation>
<PMID>2420315</PMID>
</reference>
<reference>
<citation>Argon laser photocoagulation for neovascular maculopathy. Three-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 May;104(5):694-701.</citation>
<PMID>2423061</PMID>
</reference>
<reference>
<citation>Krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1987 Nov;105(11):1499-507. doi: 10.1001/archopht.1987.01060110045029.</citation>
<PMID>2445326</PMID>
</reference>
<reference>
<citation>Chamberlin JA, Bressler NM, Bressler SB, Elman MJ, Murphy RP, Flood TP, Hawkins BS, Maguire MG, Fine SL. The use of fundus photographs and fluorescein angiograms in the identification and treatment of choroidal neovascularization in the Macular Photocoagulation Study. The Macular Photocoagulation Study Group. Ophthalmology. 1989 Oct;96(10):1526-34. doi: 10.1016/s0161-6420(89)32707-2.</citation>
<PMID>2479899</PMID>
</reference>
<reference>
<citation>Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Macular Photocoagulation Study Group. Arch Ophthalmol. 1989 Mar;107(3):344-52. doi: 10.1001/archopht.1989.01070010354023.</citation>
<PMID>2466454</PMID>
</reference>
<reference>
<citation>Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):816-24. doi: 10.1001/archopht.1990.01070080058036.</citation>
<PMID>1693496</PMID>
</reference>
<reference>
<citation>Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):825-31. doi: 10.1001/archopht.1990.01070080067037.</citation>
<PMID>1693497</PMID>
</reference>
<reference>
<citation>Krypton laser photocoagulation for idiopathic neovascular lesions. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):832-7.</citation>
<PMID>1693498</PMID>
</reference>
<reference>
<citation>Bressler SB, Maguire MG, Bressler NM, Fine SL. Relationship of drusen and abnormalities of the retinal pigment epithelium to the prognosis of neovascular macular degeneration. The Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Oct;108(10):1442-7. doi: 10.1001/archopht.1990.01070120090035.</citation>
<PMID>1699513</PMID>
</reference>
<reference>
<citation>Bressler NM, Bressler SB, Alexander J, Javornik N, Fine SL, Murphy RP. Loculated fluid. A previously undescribed fluorescein angiographic finding in choroidal neovascularization associated with macular degeneration. Macular Photocoagulation Study Reading Center. Arch Ophthalmol. 1991 Feb;109(2):211-5. doi: 10.1001/archopht.1991.01080020057043.</citation>
<PMID>1704212</PMID>
</reference>
<reference>
<citation>Argon laser photocoagulation for neovascular maculopathy. Five-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Aug;109(8):1109-14. Erratum In: Arch Ophthalmol 1992 Jun;110(6):761.</citation>
<PMID>1714270</PMID>
</reference>
<reference>
<citation>Laser photocoagulation of subfoveal recurrent neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Sep;109(9):1232-41. doi: 10.1001/archopht.1991.01080090056026.</citation>
<PMID>1718251</PMID>
</reference>
<reference>
<citation>Subfoveal neovascular lesions in age-related macular degeneration. Guidelines for evaluation and treatment in the macular photocoagulation study. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Sep;109(9):1242-57.</citation>
<PMID>1718252</PMID>
</reference>
<reference>
<citation>Birch DG, Anderson JL, Fish GE, Jost BF. Pattern-reversal electroretinographic acuity in untreated eyes with subfoveal neovascular membranes. Invest Ophthalmol Vis Sci. 1992 Jun;33(7):2097-104.</citation>
<PMID>1376721</PMID>
</reference>
<reference>
<citation>Orr PR, Blackhurst DW, Hawkins BS. Patient and clinic factors predictive of missed visits and inactive status in a multicenter clinical trial. The Macular Photocoagulation Study Group. Control Clin Trials. 1992 Feb;13(1):40-9. doi: 10.1016/0197-2456(92)90028-x.</citation>
<PMID>1315662</PMID>
</reference>
<reference>
<citation>Birch DG, Anderson JL, Fish GE, Jost BF. Pattern-reversal electroretinographic follow-up of laser photocoagulation for subfoveal neovascular lesions in age-related macular degeneration. Am J Ophthalmol. 1993 Aug 15;116(2):148-55. doi: 10.1016/s0002-9394(14)71278-4.</citation>
<PMID>8352298</PMID>
</reference>
<reference>
<citation>Fine SL; The case for treating subfoveal neovascularization in patients with age-related macular degeneration, Franklin RM (ed): Retina and Vitreous., Proceedings of the Symposium on Retina and Vitreous, New Orleans Academy of Ophthalmology, New York, Kugler Publications 1993:29-30</citation>
</reference>
<reference>
<citation>Five-year follow-up of fellow eyes of patients with age-related macular degeneration and unilateral extrafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1993 Sep;111(9):1189-99. doi: 10.1001/archopht.1993.01090090041018.</citation>
<PMID>7689826</PMID>
</reference>
<reference>
<citation>Laser photocoagulation of subfoveal neovascular lesions of age-related macular degeneration. Updated findings from two clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1993 Sep;111(9):1200-9. doi: 10.1001/archopht.1993.01090090052019.</citation>
<PMID>7689827</PMID>
</reference>
<reference>
<citation>Visual outcome after laser photocoagulation for subfoveal choroidal neovascularization secondary to age-related macular degeneration. The influence of initial lesion size and initial visual acuity. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):480-8. doi: 10.1001/archopht.1994.01090160056023.</citation>
<PMID>7512334</PMID>
</reference>
<reference>
<citation>Persistent and recurrent neovascularization after laser photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):489-99. doi: 10.1001/archopht.1994.01090160065024.</citation>
<PMID>7512335</PMID>
</reference>
<reference>
<citation>Laser photocoagulation for juxtafoveal choroidal neovascularization. Five-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):500-9.</citation>
<PMID>7512336</PMID>
</reference>
<reference>
<citation>Evaluation of argon green vs krypton red laser for photocoagulation of subfoveal choroidal neovascularization in the macular photocoagulation study. Macular Photocoagulation Study (MPS) Group. Arch Ophthalmol. 1994 Sep;112(9):1176-84. doi: 10.1001/archopht.1994.01090210060017.</citation>
<PMID>7522004</PMID>
</reference>
<reference>
<citation>Laser photocoagulation for neovascular lesions nasal to the fovea. Results from clinical trials for lesions secondary to ocular histoplasmosis or idiopathic causes. Macular Photocoagulation Study Group. Arch Ophthalmol. 1995 Jan;113(1):56-61.</citation>
<PMID>7529993</PMID>
</reference>
<reference>
<citation>The influence of treatment extent on the visual acuity of eyes treated with Krypton laser for juxtafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1995 Feb;113(2):190-4. doi: 10.1001/archopht.1995.01100020074032.</citation>
<PMID>7532395</PMID>
</reference>
<reference>
<citation>Occult choroidal neovascularization. Influence on visual outcome in patients with age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1996 Apr;114(4):400-12. Erratum In: Arch Ophthalmol 1996 Aug;114(8):1023.</citation>
<PMID>8602776</PMID>
</reference>
<reference>
<citation>Five-year follow-up of fellow eyes of individuals with ocular histoplasmosis and unilateral extrafoveal or juxtafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1996 Jun;114(6):677-88. doi: 10.1001/archopht.1996.01100130669006.</citation>
<PMID>8639078</PMID>
</reference>
<reference>
<citation>Risk factors for choroidal neovascularization in the second eye of patients with juxtafoveal or subfoveal choroidal neovascularization secondary to age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1997 Jun;115(6):741-7. doi: 10.1001/archopht.1997.01100150743009.</citation>
<PMID>9194725</PMID>
</reference>
<verification_date>June 2002</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>photocoagulation</keyword>
<keyword>argon blue-green laser</keyword>
<keyword>krypton red laser</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Histoplasmosis</mesh_term>
<mesh_term>Macular Degeneration</mesh_term>
<mesh_term>Choroidal Neovascularization</mesh_term>
<mesh_term>Neovascularization, Pathologic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000158
org study id: NEI-60
nct id: NCT00000158
lead sponsor:
To evaluate laser treatment of choroidal neovascularization (CNV) through randomized,
controlled clinical trials. The Macular Photocoagulation Study (MPS) consisted of three sets
of randomized, controlled clinical trials. Change in best-corrected visual acuity from
baseline was the primary outcome for all MPS trials. Other measures of vision are evaluated
in each set of trials. The purpose of each is described below.
Argon Study: To determine whether argon blue-green laser photocoagulation of leaking abnormal
blood vessels in choroidal neovascular membranes outside the fovea (200 to 2,500 microns from
the center of the foveal avascular zone [FAZ]) is of benefit in preventing or delaying loss
of central vision in patients with age-related (senile) macular degeneration (AMD), presumed
ocular histoplasmosis (POH), and idiopathic neovascular membranes (INVM). A separate trial
was conducted for each of the three underlying conditions.
Krypton Study: To determine whether krypton red laser photocoagulation of choroidal
neovascular lesions with the posterior border 1 to 199 microns from the center of the FAZ is
of benefit in preventing or delaying large losses of visual acuity in patients with AMD, POH,
and INVM. A separate trial was conducted for each of the three underlying conditions.
Foveal Study: To determine whether laser photocoagulation is of benefit in preventing or
delaying further visual acuity loss in patients with new (never treated) or recurrent
(previously treated with laser photocoagulation) choroidal neovascularization under the
center of the FAZ. Two separate trials, one for each type of lesion, were carried out.
In each randomized trial conducted by the MPS Group, focal laser photocoagulation was
compared to observation without treatment. Patients were assigned to laser treatment or to
observation with equal probability. The first set of MPS randomized trials, the Argon Study,
focused on the effectiveness of photocoagulation with argon blue-green laser in eyes with
discrete extrafoveal choroidal neovascularization. The study investigators, who began
recruiting patients in 1979, estimated that 550 patients with AMD and 750 with POH would be
required. Follow-up was to continue for 5 years to determine whether argon laser
photocoagulation treatment could prevent or delay visual acuity loss in these patients.
After the initiation of the Argon Study, a new krypton red laser became available. The new
wavelength offered theoretical advantages over the argon laser for treating CNV that extended
inside the FAZ of the macula. The Krypton Study design was analogous to the Argon Study, with
the investigation of three underlying conditions, except that CNV was closer to the FAZ
center.
The third set of MPS clinical trials, the Foveal Study, was designed to determine whether
laser photocoagulation was effective for delaying or preventing further visual acuity loss in
AMD patients who have subfoveal CNV. Among patients assigned to laser treatment in the Foveal
Study, argon laser treatment was compared with krypton red laser treatment of these lesions.
The investigators originally projected that about 350 patients would be required for each
clinical trial of the Foveal Study.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Argon Blue-Green Laser Photocoagulation
criteria:
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Changing the protocol: a case report from the Macular Photocoagulation Study. Macular Photocoagulation Study Group. Control Clin Trials. 1984 Sep;5(3):203-16. doi: 10.1016/0197-2456(84)90024-2.
PMID: 6488805
citation: Hillis A, Maguire M, Hawkins BS, Newhouse MM. The Markov process as a general method for nonparametric analysis of right-censored medical data. J Chronic Dis. 1986;39(8):595-604. doi: 10.1016/0021-9681(86)90184-0.
PMID: 3525597
citation: Blackhurst DW, Maguire MG. Reproducibility of refraction and visual acuity measurement under a standard protocol. The Macular Photocoagulation Study Group. Retina. 1989;9(3):163-9.
PMID: 2480626
citation: Hawkins BS, Prior MJ, Fisher MR, Blackhurst DW. Relationship between rate of patient enrollment and quality of clinical center performance in two multicenter trials in ophthalmology. Control Clin Trials. 1990 Oct;11(5):374-94. doi: 10.1016/0197-2456(90)90177-4.
PMID: 1963130
citation: Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol. 1982 Jun;100(6):912-8. doi: 10.1001/archopht.1982.01030030920003.
PMID: 7046707
citation: Argon laser photocoagulation for ocular histoplasmosis. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1347-57. doi: 10.1001/archopht.1983.01040020349002.
PMID: 6193771
citation: Argon laser photocoagulation for idiopathic neovascularization. Results of a randomized clinical trial. Arch Ophthalmol. 1983 Sep;101(9):1358-61. doi: 10.1001/archopht.1983.01040020360003.
PMID: 6193772
citation: Fine SL. Early detection of extrafoveal neovascular membranes by daily central field evaluation. Ophthalmology. 1985 May;92(5):603-9. doi: 10.1016/s0161-6420(85)33995-7.
PMID: 2409502
citation: Recurrent choroidal neovascularization after argon laser photocoagulation for neovascular maculopathy. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 Apr;104(4):503-12. doi: 10.1001/archopht.1986.01050160059012.
PMID: 2420315
citation: Argon laser photocoagulation for neovascular maculopathy. Three-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1986 May;104(5):694-701.
PMID: 2423061
citation: Krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1987 Nov;105(11):1499-507. doi: 10.1001/archopht.1987.01060110045029.
PMID: 2445326
citation: Chamberlin JA, Bressler NM, Bressler SB, Elman MJ, Murphy RP, Flood TP, Hawkins BS, Maguire MG, Fine SL. The use of fundus photographs and fluorescein angiograms in the identification and treatment of choroidal neovascularization in the Macular Photocoagulation Study. The Macular Photocoagulation Study Group. Ophthalmology. 1989 Oct;96(10):1526-34. doi: 10.1016/s0161-6420(89)32707-2.
PMID: 2479899
citation: Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of ocular histoplasmosis. Macular Photocoagulation Study Group. Arch Ophthalmol. 1989 Mar;107(3):344-52. doi: 10.1001/archopht.1989.01070010354023.
PMID: 2466454
citation: Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):816-24. doi: 10.1001/archopht.1990.01070080058036.
PMID: 1693496
citation: Persistent and recurrent neovascularization after krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):825-31. doi: 10.1001/archopht.1990.01070080067037.
PMID: 1693497
citation: Krypton laser photocoagulation for idiopathic neovascular lesions. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):832-7.
PMID: 1693498
citation: Bressler SB, Maguire MG, Bressler NM, Fine SL. Relationship of drusen and abnormalities of the retinal pigment epithelium to the prognosis of neovascular macular degeneration. The Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Oct;108(10):1442-7. doi: 10.1001/archopht.1990.01070120090035.
PMID: 1699513
citation: Bressler NM, Bressler SB, Alexander J, Javornik N, Fine SL, Murphy RP. Loculated fluid. A previously undescribed fluorescein angiographic finding in choroidal neovascularization associated with macular degeneration. Macular Photocoagulation Study Reading Center. Arch Ophthalmol. 1991 Feb;109(2):211-5. doi: 10.1001/archopht.1991.01080020057043.
PMID: 1704212
citation: Argon laser photocoagulation for neovascular maculopathy. Five-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Aug;109(8):1109-14. Erratum In: Arch Ophthalmol 1992 Jun;110(6):761.
PMID: 1714270
citation: Laser photocoagulation of subfoveal recurrent neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Sep;109(9):1232-41. doi: 10.1001/archopht.1991.01080090056026.
PMID: 1718251
citation: Subfoveal neovascular lesions in age-related macular degeneration. Guidelines for evaluation and treatment in the macular photocoagulation study. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Sep;109(9):1242-57.
PMID: 1718252
citation: Birch DG, Anderson JL, Fish GE, Jost BF. Pattern-reversal electroretinographic acuity in untreated eyes with subfoveal neovascular membranes. Invest Ophthalmol Vis Sci. 1992 Jun;33(7):2097-104.
PMID: 1376721
citation: Orr PR, Blackhurst DW, Hawkins BS. Patient and clinic factors predictive of missed visits and inactive status in a multicenter clinical trial. The Macular Photocoagulation Study Group. Control Clin Trials. 1992 Feb;13(1):40-9. doi: 10.1016/0197-2456(92)90028-x.
PMID: 1315662
citation: Birch DG, Anderson JL, Fish GE, Jost BF. Pattern-reversal electroretinographic follow-up of laser photocoagulation for subfoveal neovascular lesions in age-related macular degeneration. Am J Ophthalmol. 1993 Aug 15;116(2):148-55. doi: 10.1016/s0002-9394(14)71278-4.
PMID: 8352298
citation: Fine SL; The case for treating subfoveal neovascularization in patients with age-related macular degeneration, Franklin RM (ed): Retina and Vitreous., Proceedings of the Symposium on Retina and Vitreous, New Orleans Academy of Ophthalmology, New York, Kugler Publications 1993:29-30
citation: Five-year follow-up of fellow eyes of patients with age-related macular degeneration and unilateral extrafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1993 Sep;111(9):1189-99. doi: 10.1001/archopht.1993.01090090041018.
PMID: 7689826
citation: Laser photocoagulation of subfoveal neovascular lesions of age-related macular degeneration. Updated findings from two clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1993 Sep;111(9):1200-9. doi: 10.1001/archopht.1993.01090090052019.
PMID: 7689827
citation: Visual outcome after laser photocoagulation for subfoveal choroidal neovascularization secondary to age-related macular degeneration. The influence of initial lesion size and initial visual acuity. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):480-8. doi: 10.1001/archopht.1994.01090160056023.
PMID: 7512334
citation: Persistent and recurrent neovascularization after laser photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):489-99. doi: 10.1001/archopht.1994.01090160065024.
PMID: 7512335
citation: Laser photocoagulation for juxtafoveal choroidal neovascularization. Five-year results from randomized clinical trials. Macular Photocoagulation Study Group. Arch Ophthalmol. 1994 Apr;112(4):500-9.
PMID: 7512336
citation: Evaluation of argon green vs krypton red laser for photocoagulation of subfoveal choroidal neovascularization in the macular photocoagulation study. Macular Photocoagulation Study (MPS) Group. Arch Ophthalmol. 1994 Sep;112(9):1176-84. doi: 10.1001/archopht.1994.01090210060017.
PMID: 7522004
citation: Laser photocoagulation for neovascular lesions nasal to the fovea. Results from clinical trials for lesions secondary to ocular histoplasmosis or idiopathic causes. Macular Photocoagulation Study Group. Arch Ophthalmol. 1995 Jan;113(1):56-61.
PMID: 7529993
citation: The influence of treatment extent on the visual acuity of eyes treated with Krypton laser for juxtafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1995 Feb;113(2):190-4. doi: 10.1001/archopht.1995.01100020074032.
PMID: 7532395
citation: Occult choroidal neovascularization. Influence on visual outcome in patients with age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1996 Apr;114(4):400-12. Erratum In: Arch Ophthalmol 1996 Aug;114(8):1023.
PMID: 8602776
citation: Five-year follow-up of fellow eyes of individuals with ocular histoplasmosis and unilateral extrafoveal or juxtafoveal choroidal neovascularization. Macular Photocoagulation Study Group. Arch Ophthalmol. 1996 Jun;114(6):677-88. doi: 10.1001/archopht.1996.01100130669006.
PMID: 8639078
citation: Risk factors for choroidal neovascularization in the second eye of patients with juxtafoveal or subfoveal choroidal neovascularization secondary to age-related macular degeneration. Macular Photocoagulation Study Group. Arch Ophthalmol. 1997 Jun;115(6):741-7. doi: 10.1001/archopht.1997.01100150743009.
PMID: 9194725
mesh term: Histoplasmosis
mesh term: Macular Degeneration
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic
|
NCT0000xxxx/NCT00000159.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000159</url>
</required_header>
<id_info>
<org_study_id>NEI-61</org_study_id>
<nct_id>NCT00000159</nct_id>
</id_info>
<brief_title>Sorbinil Retinopathy Trial (SRT)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase
inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons
with insulin-dependent diabetes.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
During the last two decades, vision researchers have studied intensively the role of the
enzyme aldose reductase (AR) in diabetic cataract and in other diabetic complications. The
potentially damaging effects of AR in diabetes were first discovered in the lens fiber cells.
In these cells, the enzyme catalyzes the reduction of high levels of glucose to sorbitol
through the polyol pathway and initiates a sequence of events that eventually results in
opacification of the lens. Because sorbitol (a sugar alcohol) and fructose (a subsequent
product of glucose metabolism) cannot readily diffuse across cell membranes, they become
trapped in lens fiber cells. There they accumulate at unusually high levels and exert a
significant osmotic stress, causing an influx of water and swelling of the lens fibers. Major
electrolytic and osmotic changes then occur that lead to lens opacity.

More recently, the detection of AR in the pericytes of retinal capillaries -- cells that are
involved very early in the evolution of diabetic retinopathy -- suggests that this enzyme may
also play a role in the pathogenesis of this disorder. Scientists now know that AR is present
in nerve tissue, and they speculate that in diabetes it induces the depletion of myo
-inositol, which leads to the lessening of nerve conduction velocity in diabetic neuropathy.

Chemicals that inhibit aldose reductase have proved effective in preventing damage to the
lens, in preventing thickening of retinal capillary basement membranes in diabetic animals,
and in improving nerve conduction velocity values in patients with diabetic neuropathy.
Therefore, it is possible that AR inhibitors also may be able to prevent, delay, or halt the
development or progression of diabetic retinopathy.

To test this hypothesis, an AR inhibitor developed by Pfizer Inc., sorbinil, was studied in
this clinical trial. (Other AR inhibitors underwent study in clinical trials sponsored by
Ayerst and Alcon.) Initially, 402 patients were randomized into the double-masked treatment
period using a dosage schedule of one 250-mg tablet daily. In 1985, recruitment was
voluntarily halted by Pfizer because of several serious hypersensitivity reactions among
patients taking sorbinil in clinical trials in the United States and Europe. In November
1985, recruitment resumed, using a titrated dosage schedule of 25 mg daily for 2 weeks,
followed by 75 mg daily for 2 weeks, then 250 mg daily for the duration. A total of 497
patients participated in the study.

Followup visits were scheduled weekly for the first 4 weeks, monthly for the next 2 months,
and every 3 months thereafter. For patients assigned to the titration protocol, additional
visits were made at weeks 5 and 6. A complete history was recorded and a physical examination
was conducted every 15 months; electrocardiogram was recorded every 6 months. In addition,
patients were cautioned to note any signs of hypersensitivity.

Efficacy visits, scheduled at 9-month intervals after the first visit at 12 months, included
fundus photographs, visual acuity examinations according to the Early Treatment Diabetic
Retinopathy Study (ETDRS), red blood cell sorbitol measure, and assessment of coronary risk
factor classification.

The Sorbinil Retinopathy Trial (SRT) was a unique collaboration between private industry and
the Federal government in designing, funding, and conducting a multicenter, randomized
clinical trial. Pfizer Inc. supported 10 of the 11 participating Clinical Centers, provided
the medication, and funded the Data Coordinating Center and Fundus Photograph Reading Center.
The National Eye Institute funded the Policy, Data, and Safety Monitoring Committee and its
own participating Clinical Center.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>August 1983</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Diabetic Retinopathy</condition>
<condition>Diabetes Mellitus</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Sorbinil</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Men and women eligible for the SRT had diabetes for 1 to 15 years and were between ages 18
and 56 at the time of enrollment. They had begun taking insulin before their 41st birthday.
Their hemoglobin A1c value was within the diabetic range. On retinal examination, they
showed no evidence of or only very mild retinopathy, with no more than five microaneurysms
per eye. Women were postmenopausal, sterile, or had an IUD in place.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>56 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group. Arch Ophthalmol. 1990 Sep;108(9):1234-44. doi: 10.1001/archopht.1990.01070110050024.</citation>
<PMID>2119168</PMID>
</reference>
<reference>
<citation>The sorbinil retinopathy trial: neuropathy results. Sorbinil Retinopathy Trial Research Group. Neurology. 1993 Jun;43(6):1141-9. doi: 10.1212/wnl.43.6.1141.</citation>
<PMID>8170559</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Diabetic Retinopathy</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000159
org study id: NEI-61
nct id: NCT00000159
lead sponsor:
To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase
inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons
with insulin-dependent diabetes.
During the last two decades, vision researchers have studied intensively the role of the
enzyme aldose reductase (AR) in diabetic cataract and in other diabetic complications. The
potentially damaging effects of AR in diabetes were first discovered in the lens fiber cells.
In these cells, the enzyme catalyzes the reduction of high levels of glucose to sorbitol
through the polyol pathway and initiates a sequence of events that eventually results in
opacification of the lens. Because sorbitol (a sugar alcohol) and fructose (a subsequent
product of glucose metabolism) cannot readily diffuse across cell membranes, they become
trapped in lens fiber cells. There they accumulate at unusually high levels and exert a
significant osmotic stress, causing an influx of water and swelling of the lens fibers. Major
electrolytic and osmotic changes then occur that lead to lens opacity.
More recently, the detection of AR in the pericytes of retinal capillaries -- cells that are
involved very early in the evolution of diabetic retinopathy -- suggests that this enzyme may
also play a role in the pathogenesis of this disorder. Scientists now know that AR is present
in nerve tissue, and they speculate that in diabetes it induces the depletion of myo
-inositol, which leads to the lessening of nerve conduction velocity in diabetic neuropathy.
Chemicals that inhibit aldose reductase have proved effective in preventing damage to the
lens, in preventing thickening of retinal capillary basement membranes in diabetic animals,
and in improving nerve conduction velocity values in patients with diabetic neuropathy.
Therefore, it is possible that AR inhibitors also may be able to prevent, delay, or halt the
development or progression of diabetic retinopathy.
To test this hypothesis, an AR inhibitor developed by Pfizer Inc., sorbinil, was studied in
this clinical trial. (Other AR inhibitors underwent study in clinical trials sponsored by
Ayerst and Alcon.) Initially, 402 patients were randomized into the double-masked treatment
period using a dosage schedule of one 250-mg tablet daily. In 1985, recruitment was
voluntarily halted by Pfizer because of several serious hypersensitivity reactions among
patients taking sorbinil in clinical trials in the United States and Europe. In November
1985, recruitment resumed, using a titrated dosage schedule of 25 mg daily for 2 weeks,
followed by 75 mg daily for 2 weeks, then 250 mg daily for the duration. A total of 497
patients participated in the study.
Followup visits were scheduled weekly for the first 4 weeks, monthly for the next 2 months,
and every 3 months thereafter. For patients assigned to the titration protocol, additional
visits were made at weeks 5 and 6. A complete history was recorded and a physical examination
was conducted every 15 months; electrocardiogram was recorded every 6 months. In addition,
patients were cautioned to note any signs of hypersensitivity.
Efficacy visits, scheduled at 9-month intervals after the first visit at 12 months, included
fundus photographs, visual acuity examinations according to the Early Treatment Diabetic
Retinopathy Study (ETDRS), red blood cell sorbitol measure, and assessment of coronary risk
factor classification.
The Sorbinil Retinopathy Trial (SRT) was a unique collaboration between private industry and
the Federal government in designing, funding, and conducting a multicenter, randomized
clinical trial. Pfizer Inc. supported 10 of the 11 participating Clinical Centers, provided
the medication, and funded the Data Coordinating Center and Fundus Photograph Reading Center.
The National Eye Institute funded the Policy, Data, and Safety Monitoring Committee and its
own participating Clinical Center.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Sorbinil
criteria:
gender: All
minimum age: 18 Years
maximum age: 56 Years
healthy volunteers: No
citation: A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group. Arch Ophthalmol. 1990 Sep;108(9):1234-44. doi: 10.1001/archopht.1990.01070110050024.
PMID: 2119168
citation: The sorbinil retinopathy trial: neuropathy results. Sorbinil Retinopathy Trial Research Group. Neurology. 1993 Jun;43(6):1141-9. doi: 10.1212/wnl.43.6.1141.
PMID: 8170559
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
|
NCT0000xxxx/NCT00000160.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000160</url>
</required_header>
<id_info>
<org_study_id>NEI-62</org_study_id>
<nct_id>NCT00000160</nct_id>
</id_info>
<brief_title>Diabetic Retinopathy Study (DRS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether photocoagulation helps prevent severe visual loss from proliferative
diabetic retinopathy.

To determine whether a difference exists in the efficacy and safety of argon versus xenon
photocoagulation for proliferative diabetic retinopathy.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
By the 1950s, diabetic retinopathy had become a leading cause of blindness and visual
disability in the United States. The use of photocoagulation to treat proliferative
retinopathy gained widespread use in ophthalmic practice following its introduction in 1959.
However, only a few studies of photocoagulation incorporated any of the basic principles of
controlled clinical trials, and these involved inadequate numbers of patients. Consequently,
there has been inadequate evidence of the actual value of the procedure. Because of the
clinical importance of diabetic retinopathy and the increasing use of photocoagulation in its
management, the Diabetic Retinopathy Study (DRS) was begun in 1971. This randomized,
controlled clinical trial involved more than 1,700 patients enrolled at 15 medical centers.

One eye of each patient was randomly assigned to immediate photocoagulation and the other to
followup without treatment, regardless of the course followed by either eye. The eye chosen
for photocoagulation was randomly assigned to either of two treatment techniques, one using
an argon laser and the other a xenon arc photocoagulator. Patients were followed at 4-month
intervals according to a protocol that provided for measurement of best corrected visual
acuity.

Treatment was usually completed in one or two sittings and included scatter (panretinal)
photocoagulation extending to or beyond the vortex vein ampulae. The argon treatment
technique specified 800 to 1,600, 500-micron scatter burns of 0.1 second duration and direct
treatment of new vessels whether on or within one disc diameter of the optic disc (NVD) or
outside this area (NVE). Focal treatment was also applied to microaneurysms or other lesions
thought to be causing macular edema. Followup treatment was applied as needed at 4-month
intervals. The xenon technique was similar, but scatter burns were fewer in number, generally
of longer duration, and stronger, and direct treatment was applied only to NVE on the surface
of the retina.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>January 1972</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Diabetic Retinopathy</condition>
<condition>Blindness</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Xenon Photocoagulation</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Argon Photocoagulation</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Photocoagulation</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Patients were eligible if they had best corrected visual acuity of 20/100 or better in each
eye and the presence of proliferative diabetic retinopathy in at least one eye or severe
nonproliferative retinopathy in both eyes. They could not have had prior treatment with
photocoagulation or pituitary ablation, and both eyes had to be suitable for
photocoagulation. All eligible patients were younger than 70 years, and the examining
physician assessed the outlook for survival and availability for 5 years of followup to be
good.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/drspressrelease.asp</url>
<description>NEI Press Release-Laser Treatment Effective for Diabetic Retinopathy</description>
</link>
<reference>
<citation>Diabetic retinopathy study. Report Number 6. Design, methods, and baseline results. Report Number 7. A modification of the Airlie House classification of diabetic retinopathy. Prepared by the Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 1981 Jul;21(1 Pt 2):1-226. No abstract available.</citation>
<PMID>7195893</PMID>
</reference>
<reference>
<citation>Four risk factors for severe visual loss in diabetic retinopathy. The third report from the Diabetic Retinopathy Study. The Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1979 Apr;97(4):654-5. doi: 10.1001/archopht.1979.01020010310003.</citation>
<PMID>426679</PMID>
</reference>
<reference>
<citation>The Diabetic Retinopathy Study Research Group; Photocoagulation treatment of proliferative diabetic retinopathy: A short report of long range results., Diabetic Retinopathy Study (DRS) Report Number 4. Proceedings of the 10th Congress of the International Diabetes Federation 1979</citation>
</reference>
<reference>
<citation>Photocoagulation treatment of proliferative diabetic retinopathy: relationship of adverse treatment effects to retinopathy severity. Diabetic retinopathy study report no. 5. Dev Ophthalmol. 1981;2:248-61.</citation>
<PMID>7262408</PMID>
</reference>
<reference>
<citation>Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.</citation>
<PMID>7196564</PMID>
</reference>
<reference>
<citation>Ederer F, Podgor MJ. Assessing possible late treatment effects in stopping a clinical trial early: a case study. Diabetic Retinopathy Study report No. 9. Control Clin Trials. 1984 Dec;5(4):373-81. doi: 10.1016/s0197-2456(84)80016-1.</citation>
<PMID>6394209</PMID>
</reference>
<reference>
<citation>Rand LI, Prud'homme GJ, Ederer F, Canner PL. Factors influencing the development of visual loss in advanced diabetic retinopathy. Diabetic Retinopathy Study (DRS) Report No. 10. Invest Ophthalmol Vis Sci. 1985 Jul;26(7):983-91.</citation>
<PMID>2409053</PMID>
</reference>
<reference>
<citation>Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.</citation>
<PMID>944535</PMID>
</reference>
<reference>
<citation>Ferris FL 3rd, Podgor MJ, Davis MD. Macular edema in Diabetic Retinopathy Study patients. Diabetic Retinopathy Study Report Number 12. Ophthalmology. 1987 Jul;94(7):754-60. doi: 10.1016/s0161-6420(87)33526-2.</citation>
<PMID>3658347</PMID>
</reference>
<reference>
<citation>Kaufman SC, Ferris FL 3rd, Swartz M. Intraocular pressure following panretinal photocoagulation for diabetic retinopathy. Diabetic Retinopathy Report No. 11. Arch Ophthalmol. 1987 Jun;105(6):807-9. doi: 10.1001/archopht.1987.01060060093040.</citation>
<PMID>3555429</PMID>
</reference>
<reference>
<citation>Kaufman SC, Ferris FL 3rd, Seigel DG, Davis MD, DeMets DL. Factors associated with visual outcome after photocoagulation for diabetic retinopathy. Diabetic Retinopathy Study Report #13. Invest Ophthalmol Vis Sci. 1989 Jan;30(1):23-8.</citation>
<PMID>2912911</PMID>
</reference>
<reference>
<citation>Indications for photocoagulation treatment of diabetic retinopathy: Diabetic Retinopathy Study Report no. 14. The Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):239-53. doi: 10.1097/00004397-198702740-00004. No abstract available.</citation>
<PMID>2447027</PMID>
</reference>
<reference>
<citation>Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology. 1978 Jan;85(1):82-106. doi: 10.1016/s0161-6420(78)35693-1.</citation>
<PMID>345173</PMID>
</reference>
<verification_date>October 2003</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 1, 2006</last_update_submitted>
<last_update_submitted_qc>June 1, 2006</last_update_submitted_qc>
<last_update_posted type="Estimate">June 2, 2006</last_update_posted>
<keyword>Vision Loss</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Blindness</mesh_term>
<mesh_term>Retinal Diseases</mesh_term>
<mesh_term>Diabetic Retinopathy</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Xenon</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000160
org study id: NEI-62
nct id: NCT00000160
lead sponsor:
To determine whether photocoagulation helps prevent severe visual loss from proliferative
diabetic retinopathy.
To determine whether a difference exists in the efficacy and safety of argon versus xenon
photocoagulation for proliferative diabetic retinopathy.
By the 1950s, diabetic retinopathy had become a leading cause of blindness and visual
disability in the United States. The use of photocoagulation to treat proliferative
retinopathy gained widespread use in ophthalmic practice following its introduction in 1959.
However, only a few studies of photocoagulation incorporated any of the basic principles of
controlled clinical trials, and these involved inadequate numbers of patients. Consequently,
there has been inadequate evidence of the actual value of the procedure. Because of the
clinical importance of diabetic retinopathy and the increasing use of photocoagulation in its
management, the Diabetic Retinopathy Study (DRS) was begun in 1971. This randomized,
controlled clinical trial involved more than 1,700 patients enrolled at 15 medical centers.
One eye of each patient was randomly assigned to immediate photocoagulation and the other to
followup without treatment, regardless of the course followed by either eye. The eye chosen
for photocoagulation was randomly assigned to either of two treatment techniques, one using
an argon laser and the other a xenon arc photocoagulator. Patients were followed at 4-month
intervals according to a protocol that provided for measurement of best corrected visual
acuity.
Treatment was usually completed in one or two sittings and included scatter (panretinal)
photocoagulation extending to or beyond the vortex vein ampulae. The argon treatment
technique specified 800 to 1,600, 500-micron scatter burns of 0.1 second duration and direct
treatment of new vessels whether on or within one disc diameter of the optic disc (NVD) or
outside this area (NVE). Focal treatment was also applied to microaneurysms or other lesions
thought to be causing macular edema. Followup treatment was applied as needed at 4-month
intervals. The xenon technique was similar, but scatter burns were fewer in number, generally
of longer duration, and stronger, and direct treatment was applied only to NVE on the surface
of the retina.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Xenon Photocoagulation
intervention type: Procedure
intervention name: Argon Photocoagulation
intervention type: Procedure
intervention name: Photocoagulation
criteria:
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
url: http://www.nei.nih.gov/news/pressreleases/drspressrelease.asp
description: NEI Press Release-Laser Treatment Effective for Diabetic Retinopathy
citation: Diabetic retinopathy study. Report Number 6. Design, methods, and baseline results. Report Number 7. A modification of the Airlie House classification of diabetic retinopathy. Prepared by the Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 1981 Jul;21(1 Pt 2):1-226. No abstract available.
PMID: 7195893
citation: Four risk factors for severe visual loss in diabetic retinopathy. The third report from the Diabetic Retinopathy Study. The Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1979 Apr;97(4):654-5. doi: 10.1001/archopht.1979.01020010310003.
PMID: 426679
citation: The Diabetic Retinopathy Study Research Group; Photocoagulation treatment of proliferative diabetic retinopathy: A short report of long range results., Diabetic Retinopathy Study (DRS) Report Number 4. Proceedings of the 10th Congress of the International Diabetes Federation 1979
citation: Photocoagulation treatment of proliferative diabetic retinopathy: relationship of adverse treatment effects to retinopathy severity. Diabetic retinopathy study report no. 5. Dev Ophthalmol. 1981;2:248-61.
PMID: 7262408
citation: Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.
PMID: 7196564
citation: Ederer F, Podgor MJ. Assessing possible late treatment effects in stopping a clinical trial early: a case study. Diabetic Retinopathy Study report No. 9. Control Clin Trials. 1984 Dec;5(4):373-81. doi: 10.1016/s0197-2456(84)80016-1.
PMID: 6394209
citation: Rand LI, Prud'homme GJ, Ederer F, Canner PL. Factors influencing the development of visual loss in advanced diabetic retinopathy. Diabetic Retinopathy Study (DRS) Report No. 10. Invest Ophthalmol Vis Sci. 1985 Jul;26(7):983-91.
PMID: 2409053
citation: Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.
PMID: 944535
citation: Ferris FL 3rd, Podgor MJ, Davis MD. Macular edema in Diabetic Retinopathy Study patients. Diabetic Retinopathy Study Report Number 12. Ophthalmology. 1987 Jul;94(7):754-60. doi: 10.1016/s0161-6420(87)33526-2.
PMID: 3658347
citation: Kaufman SC, Ferris FL 3rd, Swartz M. Intraocular pressure following panretinal photocoagulation for diabetic retinopathy. Diabetic Retinopathy Report No. 11. Arch Ophthalmol. 1987 Jun;105(6):807-9. doi: 10.1001/archopht.1987.01060060093040.
PMID: 3555429
citation: Kaufman SC, Ferris FL 3rd, Seigel DG, Davis MD, DeMets DL. Factors associated with visual outcome after photocoagulation for diabetic retinopathy. Diabetic Retinopathy Study Report #13. Invest Ophthalmol Vis Sci. 1989 Jan;30(1):23-8.
PMID: 2912911
citation: Indications for photocoagulation treatment of diabetic retinopathy: Diabetic Retinopathy Study Report no. 14. The Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):239-53. doi: 10.1097/00004397-198702740-00004. No abstract available.
PMID: 2447027
citation: Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology. 1978 Jan;85(1):82-106. doi: 10.1016/s0161-6420(78)35693-1.
PMID: 345173
mesh term: Blindness
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Xenon
|
NCT0000xxxx/NCT00000161.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000161</url>
</required_header>
<id_info>
<org_study_id>NEI-63</org_study_id>
<nct_id>NCT00000161</nct_id>
</id_info>
<brief_title>Randomized Trials of Vitamin Supplements and Eye Disease</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether vitamin E supplementation reduces the risk of cataract and age-related
macular degeneration (AMD) in women.

To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women.

To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in
women.

To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in
women.

To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol
intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index,
and diabetes.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Cataract and AMD are two of the most important causes of visual impairment in older
Americans. Approximately 3.3 million people have visual impairment due to cataract. Cataract
extraction, although one of the safest and most successful of all operations, is now the most
frequently performed operation in the United States among persons older than 60, costing an
estimated $1.5 billion annually. AMD is the leading cause of new cases of blindness in
persons aged 65 and older. Approximately 25 percent of persons aged 65 years and older have
signs of AMD. The pathogenesis of AMD, however, is only partly understood, and its etiology
remains obscure. For most patients, there is no available treatment. The public health burden
imposed by cataract and AMD will only increase in the coming decades as the U.S. population
ages.

These randomized, double-masked, placebo-controlled trials will test the hypotheses that
supplementation with antioxidant vitamins and with low-dose aspirin reduces the risk of
age-related cataract and AMD. The study populations are the Women's Health Study (WHS) and
the Women's Antioxidant Cardiovascular Study (WACS). The WHS is a randomized, double-masked,
placebo-controlled trial using a 2x2 factorial design to test low-dose aspirin (100 mg on
alternate days) and vitamin E (600 IU on alternate days) in the primary prevention of
cardiovascular disease (CVD) and cancer. It is being conducted among 39,876 apparently
healthy female health professionals age 45 years and older. The WACS is a randomized,
double-masked, placebo-controlled secondary prevention trial using a 2x2x2x2 factorial design
to test antioxidant vitamins (vitamins E [600 IU on alternate days] and C [500 mg daily],
beta carotene [50 mg on alternate days]), and a combination of folate (800 mg daily), vitamin
B6 (25 mg daily), and vitamin B12 (1 mg daily) among women who are at high risk for CVD
morbidity and mortality. It is being conducted among 8,171 female health professionals, ages
40 years or older, who either have preexisting CVD or have at least three coronary risk
factors and therefore are at high risk for the development of CVD.

In addition to the randomized comparisons, the investigators will also examine risk factors
for age-related cataract and AMD in these two populations. Factors to be examined include
cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease,
height, body mass index, diabetes, and dietary factors.

In each study population, followup questionnaires were sent at 6 and 12 months after
randomization and every 12 months thereafter requesting information about development of
relevant study end points including cataract and AMD and participant compliance with study
medications. Reported diagnoses of cataract and AMD are confirmed by medical record review.
The primary analysis for the randomized studies will be incidence of AMD or cataract in the
treatment and placebo groups. Survival analysis will be used to determine whether there is a
difference in time to AMD or cataract diagnosis.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Active, not recruiting</last_known_status>
<start_date>August 1993</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Factorial Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Macular Degeneration</condition>
<condition>Cataract</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Aspirin</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Beta-Carotene</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin C</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin E</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Women's Health Study:

A participant must have met all of the following criteria:

(a) female; (b) aged 45 years or older; (c) postmenopausal or with no intention of becoming
pregnant; (d) no reported personal history of cardiovascular disease, cancer (other than
non-melanoma skin cancer), gout, peptic ulcer, chronic renal or liver disease, or other
serious illness precluding participation; (e) no reported history of serious side effects
to the study treatments; (f) not currently taking aspirin, aspirin containing medication,
or nonsteroidal anti-inflammatory drugs (NSAIDs) more than 1 day per week or, if so doing,
willing to forego use of these medications; (g) not currently taking individual supplements
of vitamin E or beta carotene more than 1 day per week; (h) not currently taking
anticoagulants or corticosteroids.

Women's Antioxidant Cardiovascular Study:

Potentially eligible female health professionals for WACS were identified from the pool of
respondents to the Women's Health Study initial mailing and must have met the following
criteria:

(a) female; (b) date of birth before January 1, 1955; (c) a reported history of myocardial
infarction (MI), stroke (CVA), angina pectoris (AP), coronary artery bypass grafting
(CABG), percutaneous transluminal angioplasty (PCTA), transient ischemic attack (TIA),
carotid endarterectomy (CEA), or peripheral artery surgery (PAS); (d) no history of cancer
(except non-melanoma skin cancer) within the past 10 years and no active liver disease or
cirrhosis; (e) pregnancy physiologically impossible due to menopause (natural or surgical)
or tubal ligation, or the participant does not intend to become pregnant in the future as
indicated on the initial WHS questionnaire; (f) no current use of a vitamin K-depleting
anticoagulant agent (e.g., Coumadin). Individuals taking aspirin or other NSAIDs were not
excluded.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>45 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<verification_date>September 2001</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Age-Related Macular Degeneration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Degeneration</mesh_term>
<mesh_term>Cataract</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Aspirin</mesh_term>
<mesh_term>Vitamins</mesh_term>
<mesh_term>Vitamin E</mesh_term>
<mesh_term>Beta Carotene</mesh_term>
<mesh_term>Carotenoids</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000161
org study id: NEI-63
nct id: NCT00000161
lead sponsor:
To determine whether vitamin E supplementation reduces the risk of cataract and age-related
macular degeneration (AMD) in women.
To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women.
To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in
women.
To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in
women.
To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol
intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index,
and diabetes.
Cataract and AMD are two of the most important causes of visual impairment in older
Americans. Approximately 3.3 million people have visual impairment due to cataract. Cataract
extraction, although one of the safest and most successful of all operations, is now the most
frequently performed operation in the United States among persons older than 60, costing an
estimated $1.5 billion annually. AMD is the leading cause of new cases of blindness in
persons aged 65 and older. Approximately 25 percent of persons aged 65 years and older have
signs of AMD. The pathogenesis of AMD, however, is only partly understood, and its etiology
remains obscure. For most patients, there is no available treatment. The public health burden
imposed by cataract and AMD will only increase in the coming decades as the U.S. population
ages.
These randomized, double-masked, placebo-controlled trials will test the hypotheses that
supplementation with antioxidant vitamins and with low-dose aspirin reduces the risk of
age-related cataract and AMD. The study populations are the Women's Health Study (WHS) and
the Women's Antioxidant Cardiovascular Study (WACS). The WHS is a randomized, double-masked,
placebo-controlled trial using a 2x2 factorial design to test low-dose aspirin (100 mg on
alternate days) and vitamin E (600 IU on alternate days) in the primary prevention of
cardiovascular disease (CVD) and cancer. It is being conducted among 39,876 apparently
healthy female health professionals age 45 years and older. The WACS is a randomized,
double-masked, placebo-controlled secondary prevention trial using a 2x2x2x2 factorial design
to test antioxidant vitamins (vitamins E [600 IU on alternate days] and C [500 mg daily],
beta carotene [50 mg on alternate days]), and a combination of folate (800 mg daily), vitamin
B6 (25 mg daily), and vitamin B12 (1 mg daily) among women who are at high risk for CVD
morbidity and mortality. It is being conducted among 8,171 female health professionals, ages
40 years or older, who either have preexisting CVD or have at least three coronary risk
factors and therefore are at high risk for the development of CVD.
In addition to the randomized comparisons, the investigators will also examine risk factors
for age-related cataract and AMD in these two populations. Factors to be examined include
cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease,
height, body mass index, diabetes, and dietary factors.
In each study population, followup questionnaires were sent at 6 and 12 months after
randomization and every 12 months thereafter requesting information about development of
relevant study end points including cataract and AMD and participant compliance with study
medications. Reported diagnoses of cataract and AMD are confirmed by medical record review.
The primary analysis for the randomized studies will be incidence of AMD or cataract in the
treatment and placebo groups. Survival analysis will be used to determine whether there is a
difference in time to AMD or cataract diagnosis.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Double
intervention type: Drug
intervention name: Aspirin
intervention type: Drug
intervention name: Beta-Carotene
intervention type: Drug
intervention name: Vitamin C
intervention type: Drug
intervention name: Vitamin E
criteria:
gender: Female
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
mesh term: Macular Degeneration
mesh term: Cataract
mesh term: Aspirin
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Beta Carotene
mesh term: Carotenoids
|
NCT0000xxxx/NCT00000162.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000162</url>
</required_header>
<id_info>
<org_study_id>NEI-64</org_study_id>
<nct_id>NCT00000162</nct_id>
</id_info>
<brief_title>Branch Vein Occlusion Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To determine whether scatter argon laser photocoagulation can prevent the development of
neovascularization.

To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous
hemorrhage.

To determine whether macular argon laser photocoagulation can improve visual acuity in eyes
with macular edema reducing vision to 20/40 or worse.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after
diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none
were proven to be effective. The only treatment that seemed at all promising in preventing
visual loss from BVO was laser photocoagulation.

Approximately 500 patients were enrolled in the study. One-half were randomly assigned to
treatment with argon laser photocoagulation; the other one-half remained untreated as
controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser
burns was applied in the drainage area of the occluded vein site, avoiding the fovea and
optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time
of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with
exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old
had to have been available for each patient. Treatment was performed under topical anesthesia
using the argon laser to achieve a grid pattern over the area of capillary leakage identified
by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea
than the edge of the foveal avascular zone and did not extend peripherally beyond the major
vascular arcade. The efficacy of treatment was judged on the basis of visual acuity
measurements as well as assessment of the subsequent development of neovascularization and/or
vitreous hemorrhage. Patients were followed for at least 3 years.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>July 1977</start_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<condition>Macular Degeneration</condition>
<condition>Neovascularization, Pathologic</condition>
<condition>Vitreous Hemorrhage</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Macular Argon Laser Photocoagulation</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Peripheral Scatter Argon Laser Photocoagulation</intervention_name>
</intervention>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Scatter Argon Laser Photocoagulation</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Patients with three types of diagnoses were accepted:

1. major BVO without neovascularization;

2. major BVO with neovascularization;

3. BVO with macular edema and reduced vision. All patients must have had onset of signs
and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200
or better, and sufficient clarity of the ocular media to permit confirmation of the
condition with fundus photography. Other eligibility criteria apply to each of the
three major groups as well as special cases such as the occurrence of bilateral
disease.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<reference>
<citation>Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82. doi: 10.1016/0002-9394(84)90316-7.</citation>
<PMID>6383055</PMID>
</reference>
<reference>
<citation>Argon laser scatter photocoagulation for prevention of neovascularization and vitreous hemorrhage in branch vein occlusion. A randomized clinical trial. Branch Vein Occlusion Study Group. Arch Ophthalmol. 1986 Jan;104(1):34-41. doi: 10.1001/archopht.1986.01050130044017.</citation>
<PMID>2417579</PMID>
</reference>
<verification_date>October 1999</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Degeneration</mesh_term>
<mesh_term>Vitreous Hemorrhage</mesh_term>
<mesh_term>Hemorrhage</mesh_term>
<mesh_term>Neovascularization, Pathologic</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000162
org study id: NEI-64
nct id: NCT00000162
lead sponsor:
To determine whether scatter argon laser photocoagulation can prevent the development of
neovascularization.
To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous
hemorrhage.
To determine whether macular argon laser photocoagulation can improve visual acuity in eyes
with macular edema reducing vision to 20/40 or worse.
Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after
diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none
were proven to be effective. The only treatment that seemed at all promising in preventing
visual loss from BVO was laser photocoagulation.
Approximately 500 patients were enrolled in the study. One-half were randomly assigned to
treatment with argon laser photocoagulation; the other one-half remained untreated as
controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser
burns was applied in the drainage area of the occluded vein site, avoiding the fovea and
optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time
of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with
exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old
had to have been available for each patient. Treatment was performed under topical anesthesia
using the argon laser to achieve a grid pattern over the area of capillary leakage identified
by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea
than the edge of the foveal avascular zone and did not extend peripherally beyond the major
vascular arcade. The efficacy of treatment was judged on the basis of visual acuity
measurements as well as assessment of the subsequent development of neovascularization and/or
vitreous hemorrhage. Patients were followed for at least 3 years.
allocation: Randomized
primary purpose: Treatment
intervention type: Procedure
intervention name: Macular Argon Laser Photocoagulation
intervention type: Procedure
intervention name: Peripheral Scatter Argon Laser Photocoagulation
intervention type: Procedure
intervention name: Scatter Argon Laser Photocoagulation
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82. doi: 10.1016/0002-9394(84)90316-7.
PMID: 6383055
citation: Argon laser scatter photocoagulation for prevention of neovascularization and vitreous hemorrhage in branch vein occlusion. A randomized clinical trial. Branch Vein Occlusion Study Group. Arch Ophthalmol. 1986 Jan;104(1):34-41. doi: 10.1001/archopht.1986.01050130044017.
PMID: 2417579
mesh term: Macular Degeneration
mesh term: Vitreous Hemorrhage
mesh term: Hemorrhage
mesh term: Neovascularization, Pathologic
|
NCT0000xxxx/NCT00000163.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000163</url>
</required_header>
<id_info>
<org_study_id>NEI-65</org_study_id>
<nct_id>NCT00000163</nct_id>
</id_info>
<brief_title>Congenital Esotropia Observational Study (CEOS)</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To observe the early course of congenital esotropia, a form of childhood strabismus. This
will determine the probability of spontaneous resolution. Researchers then will try to
correlate this finding with various aspects of the esotropia such as the (1) size of the
esotropia, (2) variability, and (3) presence of hyperopia. This information will be used to
determine the feasibility of conducting a clinical trial to assess the benefit of early
surgery for congenital esotropia and, if feasible, to refine eligibility criteria for the
trial.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Congenital esotropia is the most common form of childhood strabismus. Despite its common
occurrence, limited information is available about its early clinical course. Such data are
needed to determine the earliest age at which surgery can be safely performed without concern
that the esotropia is likely to resolve spontaneously. Although the term congenital esotropia
implies that the esotropia is present at birth, in many cases the esotropia actually develops
sometime during the first few months of life. It is well recognized that congenital esotropia
persisting through 6 months of age rarely if ever resolves spontaneously and therefore
requires surgical correction. However, it is not clear how often congenital esotropia occurs
and then resolves (at an earlier age such that surgery is not necessary) before surgery is
required.

Current clinical practice is to defer surgery for congenital esotropia until 6 to 12 months
of age. Assuming that characteristics of congenital esotropia at 2 to 4 months of age can be
identified to predict which cases will require surgery, then a trial will be warranted to
determine whether performing earlier surgery enhances the development of binocular vision.
The potential benefit to very early surgery is supported by neurophysiologic research, which
has shown that (1) congenital esotropes may be born with the innate ability to develop
binocular vision, (2) there is a critical period for development of normal binocular function
within the first few months of life that is dependent on alignment of the visual axes of the
two eyes, and (3) ocular misalignment alone, regardless of its mechanism, without a
coexisting primary cortical fusion deficit, can account for abnormal development of binocular
vision. Clinical reports have demonstrated that surgical correction of the esotropia between
6 and 12 months of age provides for enhanced development of stereoacuity compared with later
surgery. However, there are limited data on the outcomes in infants who had surgical
correction before age 6 months.

The protocol for the study is identical to usual clinical practice. Following informed
consent, two followup visits are conducted: one 2 to 4 weeks after the first examination and
the other when the child is between 28 and 32 weeks of age. The examinations will be
identical to the pediatric ophthalmologist's usual routine, and no additional procedures are
being performed specifically for the study. Management of refractive error and amblyopia is
left to the ophthalmologist's discretion. A sample size of 150 has been projected for the
study.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>December 1997</start_date>
<completion_date>July 2000</completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<condition>Esotropia</condition>
<eligibility>
<criteria>
<textblock>
Neurologically and developmentally normal infants with congenital esotropia who are between
4 and 20 weeks of age are eligible for CEOS.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>4 Weeks</minimum_age>
<maximum_age>20 Weeks</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<verification_date>September 2009</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>September 16, 2009</last_update_submitted>
<last_update_submitted_qc>September 16, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">September 17, 2009</last_update_posted>
<keyword>Congenital Esotropia</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Esotropia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000163
org study id: NEI-65
nct id: NCT00000163
lead sponsor:
To observe the early course of congenital esotropia, a form of childhood strabismus. This
will determine the probability of spontaneous resolution. Researchers then will try to
correlate this finding with various aspects of the esotropia such as the (1) size of the
esotropia, (2) variability, and (3) presence of hyperopia. This information will be used to
determine the feasibility of conducting a clinical trial to assess the benefit of early
surgery for congenital esotropia and, if feasible, to refine eligibility criteria for the
trial.
Congenital esotropia is the most common form of childhood strabismus. Despite its common
occurrence, limited information is available about its early clinical course. Such data are
needed to determine the earliest age at which surgery can be safely performed without concern
that the esotropia is likely to resolve spontaneously. Although the term congenital esotropia
implies that the esotropia is present at birth, in many cases the esotropia actually develops
sometime during the first few months of life. It is well recognized that congenital esotropia
persisting through 6 months of age rarely if ever resolves spontaneously and therefore
requires surgical correction. However, it is not clear how often congenital esotropia occurs
and then resolves (at an earlier age such that surgery is not necessary) before surgery is
required.
Current clinical practice is to defer surgery for congenital esotropia until 6 to 12 months
of age. Assuming that characteristics of congenital esotropia at 2 to 4 months of age can be
identified to predict which cases will require surgery, then a trial will be warranted to
determine whether performing earlier surgery enhances the development of binocular vision.
The potential benefit to very early surgery is supported by neurophysiologic research, which
has shown that (1) congenital esotropes may be born with the innate ability to develop
binocular vision, (2) there is a critical period for development of normal binocular function
within the first few months of life that is dependent on alignment of the visual axes of the
two eyes, and (3) ocular misalignment alone, regardless of its mechanism, without a
coexisting primary cortical fusion deficit, can account for abnormal development of binocular
vision. Clinical reports have demonstrated that surgical correction of the esotropia between
6 and 12 months of age provides for enhanced development of stereoacuity compared with later
surgery. However, there are limited data on the outcomes in infants who had surgical
correction before age 6 months.
The protocol for the study is identical to usual clinical practice. Following informed
consent, two followup visits are conducted: one 2 to 4 weeks after the first examination and
the other when the child is between 28 and 32 weeks of age. The examinations will be
identical to the pediatric ophthalmologist's usual routine, and no additional procedures are
being performed specifically for the study. Management of refractive error and amblyopia is
left to the ophthalmologist's discretion. A sample size of 150 has been projected for the
study.
criteria:
gender: All
minimum age: 4 Weeks
maximum age: 20 Weeks
healthy volunteers: No
mesh term: Esotropia
|
NCT0000xxxx/NCT00000167.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000167</url>
</required_header>
<id_info>
<org_study_id>NEI-70</org_study_id>
<nct_id>NCT00000167</nct_id>
</id_info>
<brief_title>Complications of Age-Related Macular Degeneration Prevention Trial</brief_title>
<acronym>CAPT</acronym>
<official_title>Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)</official_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To determine whether application of low-intensity laser treatment of eyes with drusen in the
macula can prevent later complications of age-related macular degeneration and thereby
preserve visual function.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Complications of age-related macular degeneration (AMD) are the leading cause of severe
vision loss among people aged 65 and over in the United States and many Western countries.
Most, (approximately 90 percent), of this vision loss is due to the neovascular (or wet) form
of AMD. The word neovascular describes the development of new, abnormal blood vessels in the
back of the eye. Unfortunately, the majority of these new vessels are not amenable to
currently available treatments.

The first sign that an eye may develop AMD is the presence of drusen, yellowish deposits
under the retina. Current data suggests that eyes with large drusen are at increased risk for
developing the vision threatening complications of AMD. Since the 1970s investigators have
reported consistently that laser photocoagulation causes a reduction in large drusen.
However, results of the effects of laser treatment on preventing later complications of AMD
have been less consistent and based on relatively small numbers of patients.

Further study into the ability of a treatment to prevent vision loss from the advanced forms
of AMD would have profound public health implications. A treatment that could reduce the risk
of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by
one half. The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) will
assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual
acuity.

The CAPT is a multi-center, prospective, randomized clinical trial designed to assess the
safety and effectiveness of low-intensity laser treatment in preventing vision loss among
patients with large drusen in both eyes. A total of 1052 participants were enrolled in the
study. Participants had one eye randomly assigned to laser treatment performed by a
CAPT-certified ophthalmologist. The other eye was not treated. Both eyes were observed
carefully for any changes for a period of five years. The effectiveness of the treatment was
assessed using the following criteria:

Change in visual acuity (primary outcome measure of the study)

Incidence of complications of AMD such as neovascularization, serous detachment of the
pigment epithelium, and geographic atrophy

Changes in contrast threshold and critical print size for reading

Quality of life assessments for patients, using the Visual Function Questionnaire 25
(VFQ-25), were conducted at the time of enrollment and at 5 years.

STUDY RESULTS:

Follow-up of patients was excellent; less than 3% of visual acuity examinations were missed.
At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had visual acuity scores
≥3 lines worse than at the initial visit (p= 1.00). The cumulative 5-year incidence rates for
treated and observed eyes for CNV were 13.3% and 13.3% (p=0.95), respectively; and for GA
were 7.4% and 7.8% (p=0.64), respectively. The contrast threshold doubled in 23.9% of treated
eyes and in 20.5% of observed eyes (p=0.40). The critical print size doubled in 29.6% of
treated eyes and in 28.4% of observed eyes (p=0.70). Seven (0.7%) treated eyes and 14 (1.3%)
observed eyes had an adverse event of a ≥6 -line loss in visual acuity in the absence of late
age-related macular degeneration or cataract.

As applied in CAPT, low intensity laser treatment did not demonstrate a clinically
significant benefit on vision in eyes of people with bilateral large drusen.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1999</start_date>
<completion_date type="Actual">June 2006</completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Prevention</primary_purpose>
<masking>Single (Outcomes Assessor)</masking>
</study_design_info>
<primary_outcome>
<measure>Change in visual acuity (3-line loss)</measure>
<time_frame>5 years</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy</measure>
<time_frame>5 years</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Changes in contrast threshold and critical print size for reading</measure>
<time_frame>5 years</time_frame>
</secondary_outcome>
<number_of_arms>1</number_of_arms>
<enrollment type="Actual">1052</enrollment>
<condition>Macular Degeneration</condition>
<arm_group>
<arm_group_label>1</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Laser treatment</description>
</arm_group>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Low-Intensity Laser Treatment</intervention_name>
<description>Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.</description>
<arm_group_label>1</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Patients eligible for CAPT can be either male or female and meet the following criteria:

Age at least 50 years old

Vision in each eye must measure 20/40 or better.

At least 10 large drusen in each eye

Available for follow-up examinations for 5 years after enrollment

Final eligibility is determined through a detailed eye examination by a CAPT-certified
ophthalmologist.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Stuart L Fine, MD</last_name>
<role>Study Chair</role>
<affiliation>Scheie Eye Institute, The University of Pennsylvania School of Medicine</affiliation>
</overall_official>
<location>
<facility>
<name>Retinal Consultants of Arizona, Ltd.</name>
<address>
<city>Mesa</city>
<state>Arizona</state>
<zip>85201</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retinal Consultants of Arizona, Ltd.</name>
<address>
<city>Peoria</city>
<state>Arizona</state>
<zip>85351</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>West Coast Retina Medical Group, Inc.</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94107</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida Eye Institute</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612-4766</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory Eye Center</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30322</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Illinois Retina Associates, S.C.</name>
<address>
<city>Harvey</city>
<state>Illinois</state>
<zip>60426</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Iowa</name>
<address>
<city>Iowa City</city>
<state>Iowa</state>
<zip>55242-1091</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine</name>
<address>
<city>Louisville</city>
<state>Kentucky</state>
<zip>40202-1594</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287-9223</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Ophthalmic Consultants of Boston</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Associate Retinal Consultants, P.C.</name>
<address>
<city>Royal Oak</city>
<state>Michigan</state>
<zip>48073</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>55905</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Barnes Retina Institute</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retina-Vitreous Center, P.A.</name>
<address>
<city>Edison</city>
<state>New Jersey</state>
<zip>08820</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retina-Vitreous Center, P.A.</name>
<address>
<city>Lakewood</city>
<state>New Jersey</state>
<zip>08701</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southeast Clinical Research Associates</name>
<address>
<city>Charlotte</city>
<state>North Carolina</state>
<zip>28204</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retina Associates of Cleveland</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44122</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Ohio State University, Department of Ophthalmology</name>
<address>
<city>Columbus</city>
<state>Ohio</state>
<zip>43210</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Casey Eye Institute</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201-4197</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Retina Northwest, P.C.</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97210</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Scheie Eye Institute</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Texas Retina Associates</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75231</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences</name>
<address>
<city>Madison</city>
<state>Wisconsin</state>
<zip>53705</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/health/clinicalstudies/</url>
<description>NEI Clinical Studies Database</description>
</link>
<verification_date>December 2007</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>March 23, 2010</last_update_submitted>
<last_update_submitted_qc>March 23, 2010</last_update_submitted_qc>
<last_update_posted type="Estimate">March 24, 2010</last_update_posted>
<responsible_party>
<name_title>Natalie Kurinij</name_title>
<organization>NEI</organization>
</responsible_party>
<keyword>Age-Related Macular Degeneration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Macular Degeneration</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000167
org study id: NEI-70
nct id: NCT00000167
lead sponsor:
has dmc: Yes
To determine whether application of low-intensity laser treatment of eyes with drusen in the
macula can prevent later complications of age-related macular degeneration and thereby
preserve visual function.
Complications of age-related macular degeneration (AMD) are the leading cause of severe
vision loss among people aged 65 and over in the United States and many Western countries.
Most, (approximately 90 percent), of this vision loss is due to the neovascular (or wet) form
of AMD. The word neovascular describes the development of new, abnormal blood vessels in the
back of the eye. Unfortunately, the majority of these new vessels are not amenable to
currently available treatments.
The first sign that an eye may develop AMD is the presence of drusen, yellowish deposits
under the retina. Current data suggests that eyes with large drusen are at increased risk for
developing the vision threatening complications of AMD. Since the 1970s investigators have
reported consistently that laser photocoagulation causes a reduction in large drusen.
However, results of the effects of laser treatment on preventing later complications of AMD
have been less consistent and based on relatively small numbers of patients.
Further study into the ability of a treatment to prevent vision loss from the advanced forms
of AMD would have profound public health implications. A treatment that could reduce the risk
of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by
one half. The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) will
assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual
acuity.
The CAPT is a multi-center, prospective, randomized clinical trial designed to assess the
safety and effectiveness of low-intensity laser treatment in preventing vision loss among
patients with large drusen in both eyes. A total of 1052 participants were enrolled in the
study. Participants had one eye randomly assigned to laser treatment performed by a
CAPT-certified ophthalmologist. The other eye was not treated. Both eyes were observed
carefully for any changes for a period of five years. The effectiveness of the treatment was
assessed using the following criteria:
Change in visual acuity (primary outcome measure of the study)
Incidence of complications of AMD such as neovascularization, serous detachment of the
pigment epithelium, and geographic atrophy
Changes in contrast threshold and critical print size for reading
Quality of life assessments for patients, using the Visual Function Questionnaire 25
(VFQ-25), were conducted at the time of enrollment and at 5 years.
STUDY RESULTS:
Follow-up of patients was excellent; less than 3% of visual acuity examinations were missed.
At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had visual acuity scores
≥3 lines worse than at the initial visit (p= 1.00). The cumulative 5-year incidence rates for
treated and observed eyes for CNV were 13.3% and 13.3% (p=0.95), respectively; and for GA
were 7.4% and 7.8% (p=0.64), respectively. The contrast threshold doubled in 23.9% of treated
eyes and in 20.5% of observed eyes (p=0.40). The critical print size doubled in 29.6% of
treated eyes and in 28.4% of observed eyes (p=0.70). Seven (0.7%) treated eyes and 14 (1.3%)
observed eyes had an adverse event of a ≥6 -line loss in visual acuity in the absence of late
age-related macular degeneration or cataract.
As applied in CAPT, low intensity laser treatment did not demonstrate a clinically
significant benefit on vision in eyes of people with bilateral large drusen.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in visual acuity (3-line loss)
time frame: 5 years
measure: Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy
time frame: 5 years
measure: Changes in contrast threshold and critical print size for reading
time frame: 5 years
arm group label: 1
arm group type: Experimental
description: Laser treatment
intervention type: Procedure
intervention name: Low-Intensity Laser Treatment
description: Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.
arm group label: 1
criteria:
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Stuart L Fine, MD
role: Study Chair
affiliation: Scheie Eye Institute, The University of Pennsylvania School of Medicine
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.nei.nih.gov/health/clinicalstudies/
description: NEI Clinical Studies Database
name title: Natalie Kurinij
organization: NEI
mesh term: Macular Degeneration
|
NCT0000xxxx/NCT00000168.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000168</url>
</required_header>
<id_info>
<org_study_id>NEI-71</org_study_id>
<secondary_id>5U10EY008057</secondary_id>
<nct_id>NCT00000168</nct_id>
</id_info>
<brief_title>Longitudinal Study of Ocular Complications of AIDS (LSOCA)</brief_title>
<acronym>LSOCA</acronym>
<official_title>Studies of Ocular Complications of AIDS (SOCA)</official_title>
<sponsors>
<lead_sponsor>
<agency>Johns Hopkins Bloomberg School of Public Health</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Johns Hopkins Bloomberg School of Public Health</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
To monitor trends over time, in the incidence of CMV retinitis and other ocular complications
of AIDS

To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune
status on the risk of developing CMV retinitis and other ocular complications of AIDS

To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a
population at high risk for CMV retinitis and other ocular complications of AIDS

To evaluate the effects of treatments for CMV retinitis and other ocular complications on
visual function, quality of life, and survival.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Ocular abnormalities in patients with AIDS were first reported in 1982. The most common
finding is a non-infectious "HIV retinopathy", characterized by cotton wool spots,
intraretinal hemorrhages, and/or microaneurysms. These changes occur in approximately 50
percent of patients with AIDS. HIV retinopathy alone is not typically associated with
clinical loss of vision, but functional deficits in patients with AIDS without other ocular
complications may be due to this phenomenon.

CMV retinitis has had the most clinical importance of all the associated complications of
AIDS. It is commonly seen in late stage AIDS, and even when treated has the potential to
cause substantial loss of vision. CMV retinitis is also the most costly AIDS-related
opportunistic infection; the mean monthly cost of treatment has been estimated at $7,825. The
incidence of CMV retinitis has varied with changes in the therapeutic and prophylactic
strategies for AIDS and its complications. It has been on the decline in recent years related
to the increased use of highly active anti-retroviral therapy (HAART).

Other ocular complications of AIDS such as ocular toxoplasmosis, herpes zoster retinitis, and
pneumocystis choroidopathy occur less frequently than CMV retinitis and HIV retinopathy.
Their frequency has also changed over the course of the AIDS epidemic.

Because the epidemiology of AIDS is rapidly evolving, with HIV becoming more like a chronic
disease, new information is needed on the incidence and course of ocular complications. We
have little information about the effect of HAART therapy over time on changes in immune
status and the risk of ocular complications of AIDS. More information is also needed to
determine who is at risk for developing ocular complications of AIDS, and how treatment is
affecting their visual function, quality of life, and survival.

The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is prospective observational
study of patients with AIDS. Patients with a prior diagnosis of AIDS according to the 1993
Centers for Disease Control and Prevention (CDC) criteria with or without ocular
complications will be enrolled over a 4 year period. Approximately 2,000 patients will be
enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between
300 and 600 patients. Followup visits for patients without ocular complications will be
scheduled every 6 months. Followup visits for patients with ocular complications at baseline
or diagnosed during followup will be every 3 months. Followup data will include eye
examinations, fundus photographs, visual function testing, medical history, hematology and
serum chemistry, and collection of plasma and blood cells for banking. Analysis of banked
specimens will include HIV RNA levels and CMV DNA levels.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>August 1998</start_date>
<completion_date type="Actual">August 2013</completion_date>
<primary_completion_date type="Actual">August 2013</primary_completion_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<observational_model>Cohort</observational_model>
<time_perspective>Prospective</time_perspective>
</study_design_info>
<primary_outcome>
<measure>incidence of CMV retinitis, other ocular complications, mortality.</measure>
<time_frame>Until one year after the enrollment of the last patient.</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>incidence of sequelae of AIDS-related eye disease (e.g., retinal detachments), incidence of complications of therapy, and long-term outcomes of ocular complications (e.g., visual function, quality of life).</measure>
<time_frame>Until one year after the enrollment of the last patient.</time_frame>
</secondary_outcome>
<enrollment type="Actual">2392</enrollment>
<condition>HIV Infections</condition>
<condition>Acquired Immunodeficiency Syndrome</condition>
<condition>Cytomegalovirus Retinitis</condition>
<biospec_retention>Samples With DNA</biospec_retention>
<biospec_descr>
<textblock>
Laboratory studies will include hematology serum chemistry and lymphocyte subset analysis for
all patients. The amount of blood for hematology, serum chemistry, and lymphocyte subset
analysis is restricted to no more than a total of 17 mL per draw. Data existing on HIV viral
load analysis at the clinic will be collected. If HIV data are not available from medical
records within the visit time window, blood should be collected for local HIV viral load
determination.
</textblock>
</biospec_descr>
<eligibility>
<study_pop>
<textblock>
Patients with a diagnosis of AIDS according to the 1993 CDC diagnostic criteria for AIDS
and diagnosed on or after 01 January 2001 will be eligible for enrollment.
</textblock>
</study_pop>
<sampling_method>Non-Probability Sample</sampling_method>
<criteria>
<textblock>
Inclusion criteria:

- A diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention
(CDC) definition (with or without clinical symptoms of CMV retinitis or other ocular
complications of AIDS)

- Age 13 years or older

- Signed consent statement

- Patients with newly diagnosed (within 45 days of enrollment) Ocular Opportunistic
Infections (OOIs)

- Patients without a newly diagnosed Ocular Opportunistic Infection (OOI) diagnosed with
AIDS after 1 Jan 2001

Exclusion criteria:

- none.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>13 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Doug A Jabs, MD</last_name>
<role>Study Chair</role>
<affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
</overall_official>
<location>
<facility>
<name>University of California, Irvine</name>
<address>
<city>Irvine</city>
<state>California</state>
<zip>92697-4375</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Shiley Eye Center, 0946</name>
<address>
<city>La Jolla</city>
<state>California</state>
<zip>92093-0946</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jules Stein Eye Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095-7003</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Francis I. Proctor Foundation</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94143</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Bascom Palmer Eye Institute</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33136</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612-4799</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory Eye Clinic</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30322</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Division of Infectious Diseases, University of Indiana, Indianapolis</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202-2879</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>LSU Eye Center</name>
<address>
<city>New Orleans</city>
<state>Louisiana</state>
<zip>70112</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287-9217</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UMDNJ-New Jersey Medical School</name>
<address>
<city>Newark</city>
<state>New Jersey</state>
<zip>07103-2499</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Department of Ophthalmology</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10021</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of North Carolina at Chapel Hill</name>
<address>
<city>Chapel Hill</city>
<state>North Carolina</state>
<zip>27599-7040</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Hospital of the University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas Medical Branch</name>
<address>
<city>Galveston</city>
<state>Texas</state>
<zip>77555-0835</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cullen Eye Institute</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Jabs DA, Van Natta ML, Kempen JH, Reed Pavan P, Lim JI, Murphy RL, Hubbard LD. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2002 Jan;133(1):48-61. doi: 10.1016/s0002-9394(01)01322-8.</citation>
<PMID>11755839</PMID>
</reference>
<reference>
<citation>Kempen JH, Martin BK, Wu AW, Barron B, Thorne JE, Jabs DA; Studies of Ocular Complications of AIDS Researh Group. The effect of cytomegalovirus retinitis on the quality of life of patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2003 May;110(5):987-95. doi: 10.1016/S0161-6420(03)00089-7.</citation>
<PMID>12750102</PMID>
</reference>
<reference>
<citation>Jacobson MA, Maecker HT, Orr PL, D'Amico R, Van Natta M, Li XD, Pollard RB, Bredt BM; Adult AIDS Clinical Trials Group and the Studies of Ocular Complications of AIDS Research Group. Results of a cytomegalovirus (CMV)-specific CD8+/interferon- gamma+ cytokine flow cytometry assay correlate with clinical evidence of protective immunity in patients with AIDS with CMV retinitis. J Infect Dis. 2004 Apr 15;189(8):1362-73. doi: 10.1086/382964. Epub 2004 Mar 31.</citation>
<PMID>15073672</PMID>
</reference>
<reference>
<citation>Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 1. Retinitis progression. Ophthalmology. 2004 Dec;111(12):2224-31. doi: 10.1016/j.ophtha.2004.05.031.</citation>
<PMID>15582078</PMID>
</reference>
<reference>
<citation>Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 2. Second eye involvement and retinal detachment. Ophthalmology. 2004 Dec;111(12):2232-9. doi: 10.1016/j.ophtha.2004.05.028.</citation>
<PMID>15582079</PMID>
</reference>
<reference>
<citation>Weinberg DV, Holbrook JT, Hubbard LD, Davis MD, Jabs DA, Holland GN; Studies of Ocular Complications of AIDS Research Group. Clinician versus reading center assessment of cytomegalovirus retinitis lesion size. Ophthalmology. 2005 Apr;112(4):559-66. doi: 10.1016/j.ophtha.2004.11.027.</citation>
<PMID>15808244</PMID>
</reference>
<reference>
<citation>Jabs DA, Holbrook JT, Van Natta ML, Clark R, Jacobson MA, Kempen JH, Murphy RL; Studies of Ocular Complications of AIDS Research Group. Risk factors for mortality in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2005 May;112(5):771-9. doi: 10.1016/j.ophtha.2004.10.049.</citation>
<PMID>15878056</PMID>
</reference>
<reference>
<citation>Semba RD, Martin BK, Kempen JH, Thorne JE, Wu AW; Ocular Complications of AIDS Research Group. The impact of anemia on energy and physical functioning in individuals with AIDS. Arch Intern Med. 2005 Oct 24;165(19):2229-36. doi: 10.1001/archinte.165.19.2229.</citation>
<PMID>16246988</PMID>
</reference>
<reference>
<citation>Kempen JH, Min YI, Freeman WR, Holland GN, Friedberg DN, Dieterich DT, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Risk of immune recovery uveitis in patients with AIDS and cytomegalovirus retinitis. Ophthalmology. 2006 Apr;113(4):684-94. doi: 10.1016/j.ophtha.2005.10.067.</citation>
<PMID>16581429</PMID>
</reference>
<reference>
<citation>Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Munana A, Meinert CL, Jabs DA. Factors affecting attrition in a longitudinal study of patients with AIDS. AIDS Care. 2006 Oct;18(7):821-9. doi: 10.1080/09540120500466747.</citation>
<PMID>16971294</PMID>
</reference>
<reference>
<citation>Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1432-40. doi: 10.1016/j.ophtha.2006.03.021. Epub 2006 Jun 12.</citation>
<PMID>16766032</PMID>
</reference>
<reference>
<citation>Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Causes of visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1441-5. doi: 10.1016/j.ophtha.2006.03.022. Epub 2006 Jun 15.</citation>
<PMID>16781775</PMID>
</reference>
<reference>
<citation>Shah KH, Holland GN, Yu F, Van Natta M, Nusinowitz S; Studies of Ocular Complications of AIDS (SOCA) Research Group. Contrast sensitivity and color vision in HIV-infected individuals without infectious retinopathy. Am J Ophthalmol. 2006 Aug;142(2):284-92. doi: 10.1016/j.ajo.2006.03.046.</citation>
<PMID>16876510</PMID>
</reference>
<reference>
<citation>Sinclair E, Tan QX, Sharp M, Girling V, Poon C, Natta MV, Jabs DA, Inokuma M, Maecker HT, Bredt B, Jacobson MA; Studies of Ocular Complications of AIDS Research Group. Protective immunity to cytomegalovirus (CMV) retinitis in AIDS is associated with CMV-specific T cells that express interferon- gamma and interleukin-2 and have a CD8+ cell early maturational phenotype. J Infect Dis. 2006 Dec 1;194(11):1537-46. doi: 10.1086/508997. Epub 2006 Oct 26.</citation>
<PMID>17083038</PMID>
</reference>
<reference>
<citation>Thorne JE, Holbrook JT, Jabs DA, Kempen JH, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Effect of cytomegalovirus retinitis on the risk of visual acuity loss among patients with AIDS. Ophthalmology. 2007 Mar;114(3):591-8. doi: 10.1016/j.ophtha.2006.08.008. Epub 2006 Nov 22.</citation>
<PMID>17123624</PMID>
</reference>
<reference>
<citation>Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 1. Ocular diagnoses at enrollment. Ophthalmology. 2007 Apr;114(4):780-6. doi: 10.1016/j.ophtha.2006.11.008. Epub 2007 Jan 25.</citation>
<PMID>17258320</PMID>
</reference>
<reference>
<citation>Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 2. Ocular examination results at enrollment. Ophthalmology. 2007 Apr;114(4):787-93. doi: 10.1016/j.ophtha.2006.07.065. Epub 2007 Jan 8.</citation>
<PMID>17210182</PMID>
</reference>
<reference>
<citation>Jacobson MA, Tan QX, Girling V, Poon C, Van Natta M, Jabs DA, Inokuma M, Maecker HT, Bredt B, Sinclair E; Studies of Ocular Complications of AIDS Research Group. Poor predictive value of cytomegalovirus (CMV)-specific T cell assays for the development of CMV retinitis in patients with AIDS. Clin Infect Dis. 2008 Feb 1;46(3):458-66. doi: 10.1086/525853.</citation>
<PMID>18173357</PMID>
</reference>
<reference>
<citation>Freeman WR, Van Natta ML, Jabs D, Sample PA, Sadun AA, Thorne J, Shah KH, Holland GN; SOCA Research Group. Vision function in HIV-infected individuals without retinitis: report of the Studies of Ocular Complications of AIDS Research Group. Am J Ophthalmol. 2008 Mar;145(3):453-462. doi: 10.1016/j.ajo.2007.10.013. Epub 2008 Jan 11.</citation>
<PMID>18191094</PMID>
</reference>
<reference>
<citation>Jabs DA. AIDS and ophthalmology, 2008. Arch Ophthalmol. 2008 Aug;126(8):1143-6. doi: 10.1001/archopht.126.8.1143. No abstract available.</citation>
<PMID>18695113</PMID>
</reference>
<reference>
<citation>Holland GN, Kappel PJ, Van Natta ML, Palella FJ, Lyon AT, Shah KH, Pavan PR, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association between abnormal contrast sensitivity and mortality among people with acquired immunodeficiency syndrome. Am J Ophthalmol. 2010 May;149(5):807-16. doi: 10.1016/j.ajo.2009.12.019.</citation>
<PMID>20399927</PMID>
</reference>
<reference>
<citation>Hendrickson SL, Jabs DA, Van Natta M, Lewis RA, Wallace DC, O'Brien SJ. Mitochondrial haplogroups are associated with risk of neuroretinal disorder in HIV-positive patients. J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):451-5. doi: 10.1097/QAI.0b013e3181cb8319.</citation>
<PMID>20098332</PMID>
</reference>
<reference>
<citation>Sezgin E, Jabs DA, Hendrickson SL, Van Natta M, Zdanov A, Lewis RA, Smith MW, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on the development of cytomegalovirus retinitis in patients with AIDS. J Infect Dis. 2010 Aug 15;202(4):606-13. doi: 10.1086/654814.</citation>
<PMID>20617924</PMID>
</reference>
<reference>
<citation>Sezgin E, Hendrickson SL, Jabs DA, Van Natta ML, Lewis RA, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on incidence of HIV neuroretinal disorder in patients with AIDS. J Acquir Immune Defic Syndr. 2010 Aug;54(4):343-51. doi: 10.1097/QAI.0b013e3181deaf4d.</citation>
<PMID>20531015</PMID>
</reference>
<reference>
<citation>Puhan MA, Van Natta ML, Palella FJ, Addessi A, Meinert C; Ocular Complications of AIDS Research Group. Excess mortality in patients with AIDS in the era of highly active antiretroviral therapy: temporal changes and risk factors. Clin Infect Dis. 2010 Oct 15;51(8):947-56. doi: 10.1086/656415.</citation>
<PMID>20825306</PMID>
</reference>
<reference>
<citation>Jabs DA, Ahuja A, Van Natta M, Lyon A, Srivastava S, Gangaputra S; Studies of the Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: five-year outcomes. Ophthalmology. 2010 Nov;117(11):2152-61.e1-2. doi: 10.1016/j.ophtha.2010.03.031. Epub 2010 Jul 29.</citation>
<PMID>20673591</PMID>
</reference>
<reference>
<citation>Thorne JE, Van Natta ML, Jabs DA, Duncan JL, Srivastava SK; Studies of Ocular Complications of AIDS Research Group. Visual field loss in patients with cytomegalovirus retinitis. Ophthalmology. 2011 May;118(5):895-901. doi: 10.1016/j.ophtha.2010.09.017. Epub 2010 Dec 13.</citation>
<PMID>21146225</PMID>
</reference>
<reference>
<citation>Sezgin E, van Natta ML, Ahuja A, Lyon A, Srivastava S, Troyer JL, O'Brien SJ, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association of host genetic risk factors with the course of cytomegalovirus retinitis in patients infected with human immunodeficiency virus. Am J Ophthalmol. 2011 Jun;151(6):999-1006.e4. doi: 10.1016/j.ajo.2010.11.029. Epub 2011 Mar 10.</citation>
<PMID>21396623</PMID>
</reference>
<reference>
<citation>Holbrook JT, Colvin R, van Natta ML, Thorne JE, Bardsley M, Jabs DA; Studies of Ocular Complications of AIDS (SOCA) Research Group. Evaluation of the United States public health service guidelines for discontinuation of anticytomegalovirus therapy after immune recovery in patients with cytomegalovirus retinitis. Am J Ophthalmol. 2011 Oct;152(4):628-637.e1. doi: 10.1016/j.ajo.2011.04.007. Epub 2011 Jul 13.</citation>
<PMID>21742304</PMID>
</reference>
<reference>
<citation>Puhan MA, Ahuja A, Van Natta ML, Ackatz LE, Meinert C; Studies of Ocular Complications of AIDS Research Group. Interviewer versus self-administered health-related quality of life questionnaires - does it matter? Health Qual Life Outcomes. 2011 May 10;9:30. doi: 10.1186/1477-7525-9-30.</citation>
<PMID>21554737</PMID>
</reference>
<reference>
<citation>Gangaputra S, Pak JW, Peng Q, Hubbard LD, Thayer D, Krason Z, Joyce J, Danis RP; Studies of the Ocular Complications of AIDS Research Group. Transition from film to digital fundus photography in the Longitudinal Studies of the Ocular Complications of AIDS. Retina. 2012 Mar;32(3):600-5. doi: 10.1097/IAE.0b013e318221592f.</citation>
<PMID>21857393</PMID>
</reference>
<reference>
<citation>Gangaputra S, Kalyani PS, Fawzi AA, Van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with disease-associated factors and mortality. Am J Ophthalmol. 2012 Mar;153(3):434-444.e1. doi: 10.1016/j.ajo.2011.08.028. Epub 2011 Oct 22.</citation>
<PMID>22019225</PMID>
</reference>
<reference>
<citation>Kalyani PS, Fawzi AA, Gangaputra S, van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with visual function. Am J Ophthalmol. 2012 Mar;153(3):428-433.e1. doi: 10.1016/j.ajo.2011.08.027. Epub 2011 Oct 22.</citation>
<PMID>22019221</PMID>
</reference>
<reference>
<citation>Sugar EA, Jabs DA, Ahuja A, Thorne JE, Danis RP, Meinert CL; Studies of the Ocular Complications of AIDS Research Group. Incidence of cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2012 Jun;153(6):1016-24.e5. doi: 10.1016/j.ajo.2011.11.014. Epub 2012 Feb 4.</citation>
<PMID>22310076</PMID>
</reference>
<reference>
<citation>Limou S, Delaneau O, van Manen D, An P, Sezgin E, Le Clerc S, Coulonges C, Troyer JL, Veldink JH, van den Berg LH, Spadoni JL, Taing L, Labib T, Montes M, Delfraissy JF, Schachter F, O'Brien SJ, Buchbinder S, van Natta ML, Jabs DA, Froguel P, Schuitemaker H, Winkler CA, Zagury JF. Multicohort genomewide association study reveals a new signal of protection against HIV-1 acquisition. J Infect Dis. 2012 Apr 1;205(7):1155-62. doi: 10.1093/infdis/jis028. Epub 2012 Feb 23.</citation>
<PMID>22362864</PMID>
</reference>
<reference>
<citation>Kalyani PS, Holland GN, Fawzi AA, Arantes TE, Yu F, Sadun AA; Studies of the Ocular Complications of AIDS Research Group. Association between retinal nerve fiber layer thickness and abnormalities of vision in people with human immunodeficiency virus infection. Am J Ophthalmol. 2012 Apr;153(4):734-42, 742.e1. doi: 10.1016/j.ajo.2011.09.019. Epub 2012 Jan 15.</citation>
<PMID>22245459</PMID>
</reference>
<reference>
<citation>Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24.</citation>
<PMID>22534149</PMID>
</reference>
<reference>
<citation>Kempen JH, Sugar EA, Lyon AT, Lewis RA, Jabs DA, Heinemann MH, Dunn JP; Studies of Ocular Complications of AIDS Research Group. Risk of cataract in persons with cytomegalovirus retinitis and the acquired immune deficiency syndrome. Ophthalmology. 2012 Nov;119(11):2343-50. doi: 10.1016/j.ophtha.2012.05.044. Epub 2012 Jul 30.</citation>
<PMID>22853972</PMID>
</reference>
<reference>
<citation>Kozak I, Ahuja A, Gangaputra S, Van Natta ML, Thorne JE, Freeman WR. Optic nerve head morphology and visual field function in patients with AIDS and without infectious retinitis. Ocul Immunol Inflamm. 2012 Oct;20(5):342-8. doi: 10.3109/09273948.2012.694552. Epub 2012 Jun 14.</citation>
<PMID>22697270</PMID>
</reference>
<reference>
<citation>Gangaputra S, Drye L, Vaidya V, Thorne JE, Jabs DA, Lyon AT; Studies of the Ocular Complications of AIDS (SOCA) Research Group. Non-cytomegalovirus ocular opportunistic infections in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2013 Feb;155(2):206-212.e5. doi: 10.1016/j.ajo.2012.07.019. Epub 2012 Oct 12.</citation>
<PMID>23068916</PMID>
</reference>
<reference>
<citation>Jabs DA, Ahuja A, Van Natta M, Dunn JP, Yeh S; Studies of the Ocular Complications of AIDS Research Group. Comparison of treatment regimens for cytomegalovirus retinitis in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2013 Jun;120(6):1262-70. doi: 10.1016/j.ophtha.2012.11.023. Epub 2013 Feb 16.</citation>
<PMID>23419804</PMID>
</reference>
<reference>
<citation>Krauskopf K, Van Natta ML, Danis RP, Gangaputra S, Ackatz L, Addessi A, Federman AD, Branch AD, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Correlates of hypertension in patients with AIDS in the era of highly active antiretroviral therapy. J Int Assoc Provid AIDS Care. 2013 Sep-Oct;12(5):325-33. doi: 10.1177/2325957413491432.</citation>
<PMID>23764503</PMID>
</reference>
<reference>
<citation>Branch AD, Drye LT, Van Natta ML, Sezgin E, Fishman SL, Dieterich DT, Meinert CL, Jabs DA. Evaluation of hepatitis C virus as a risk factor for HIV-associated neuroretinal disorder. Clin Infect Dis. 2013 Dec;57(11):1618-25. doi: 10.1093/cid/cit550. Epub 2013 Sep 30.</citation>
<PMID>24081683</PMID>
</reference>
<reference>
<citation>Serrano-Villar S, Sainz T, Lee SA, Hunt PW, Sinclair E, Shacklett BL, Ferre AL, Hayes TL, Somsouk M, Hsue PY, Van Natta ML, Meinert CL, Lederman MM, Hatano H, Jain V, Huang Y, Hecht FM, Martin JN, McCune JM, Moreno S, Deeks SG. HIV-infected individuals with low CD4/CD8 ratio despite effective antiretroviral therapy exhibit altered T cell subsets, heightened CD8+ T cell activation, and increased risk of non-AIDS morbidity and mortality. PLoS Pathog. 2014 May 15;10(5):e1004078. doi: 10.1371/journal.ppat.1004078. eCollection 2014 May.</citation>
<PMID>24831517</PMID>
</reference>
<reference>
<citation>Hunt PW, Sinclair E, Rodriguez B, Shive C, Clagett B, Funderburg N, Robinson J, Huang Y, Epling L, Martin JN, Deeks SG, Meinert CL, Van Natta ML, Jabs DA, Lederman MM. Gut epithelial barrier dysfunction and innate immune activation predict mortality in treated HIV infection. J Infect Dis. 2014 Oct 15;210(8):1228-38. doi: 10.1093/infdis/jiu238. Epub 2014 Apr 21.</citation>
<PMID>24755434</PMID>
</reference>
<reference>
<citation>Lee SA, Sinclair E, Jain V, Huang Y, Epling L, Van Natta M, Meinert CL, Martin JN, McCune JM, Deeks SG, Lederman MM, Hecht FM, Hunt PW. Low proportions of CD28- CD8+ T cells expressing CD57 can be reversed by early ART initiation and predict mortality in treated HIV infection. J Infect Dis. 2014 Aug 1;210(3):374-82. doi: 10.1093/infdis/jiu109. Epub 2014 Feb 28.</citation>
<PMID>24585893</PMID>
</reference>
<reference>
<citation>Kozak I, Vaidya V, Van Natta ML, Pak JW, May KP, Thorne JE; Studies of the Ocular Complications of AIDS Research Group. The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis. Invest Ophthalmol Vis Sci. 2014 Jun 12;55(7):4304-12. doi: 10.1167/iovs.14-14479.</citation>
<PMID>24925880</PMID>
</reference>
<reference>
<citation>Kempen JH, Sugar EA, Varma R, Dunn JP, Heinemann MH, Jabs DA, Lyon AT, Lewis RA; Studies of Ocular Complications of AIDS Research Group. Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology. 2014 Dec;121(12):2317-24. doi: 10.1016/j.ophtha.2014.06.014. Epub 2014 Aug 8.</citation>
<PMID>25109932</PMID>
</reference>
<reference>
<citation>Jabs DA, Drye L, Van Natta ML, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Incidence and long-term outcomes of the human immunodeficiency virus neuroretinal disorder in patients with AIDS. Ophthalmology. 2015 Apr;122(4):760-8. doi: 10.1016/j.ophtha.2014.11.009. Epub 2015 Jan 16.</citation>
<PMID>25600199</PMID>
</reference>
<reference>
<citation>Jabs DA, Van Natta ML, Sezgin E, Pak JW, Danis R; Studies of the Ocular Complications of AIDS Research Group. Prevalence of intermediate-stage age-related macular degeneration in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2015 Jun;159(6):1115-1122.e1. doi: 10.1016/j.ajo.2015.01.037. Epub 2015 Mar 11.</citation>
<PMID>25769246</PMID>
</reference>
<reference>
<citation>Jabs DA, Ahuja A, Van Natta ML, Lyon AT, Yeh S, Danis R; Studies of the Ocular Complications of AIDS Research Group. Long-term Outcomes of Cytomegalovirus Retinitis in the Era of Modern Antiretroviral Therapy: Results from a United States Cohort. Ophthalmology. 2015 Jul;122(7):1452-63. doi: 10.1016/j.ophtha.2015.02.033. Epub 2015 Apr 17.</citation>
<PMID>25892019</PMID>
</reference>
<verification_date>June 2015</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 10, 2015</last_update_submitted>
<last_update_submitted_qc>June 10, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">June 12, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>Johns Hopkins Bloomberg School of Public Health</investigator_affiliation>
<investigator_full_name>Curtis Meinert</investigator_full_name>
<investigator_title>Professor</investigator_title>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>HIV Infections</mesh_term>
<mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
<mesh_term>Cytomegalovirus Retinitis</mesh_term>
<mesh_term>Retinitis</mesh_term>
<mesh_term>Immunologic Deficiency Syndromes</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000168
org study id: NEI-71
secondary id: 5U10EY008057
nct id: NCT00000168
lead sponsor:
collaborator:
has dmc: Yes
To monitor trends over time, in the incidence of CMV retinitis and other ocular complications
of AIDS
To determine the effect of highly active anti-retroviral therapy (HAART)-induced immune
status on the risk of developing CMV retinitis and other ocular complications of AIDS
To determine the characteristics (clinical, virologic, hematologic, and biochemical) of a
population at high risk for CMV retinitis and other ocular complications of AIDS
To evaluate the effects of treatments for CMV retinitis and other ocular complications on
visual function, quality of life, and survival.
Ocular abnormalities in patients with AIDS were first reported in 1982. The most common
finding is a non-infectious "HIV retinopathy", characterized by cotton wool spots,
intraretinal hemorrhages, and/or microaneurysms. These changes occur in approximately 50
percent of patients with AIDS. HIV retinopathy alone is not typically associated with
clinical loss of vision, but functional deficits in patients with AIDS without other ocular
complications may be due to this phenomenon.
CMV retinitis has had the most clinical importance of all the associated complications of
AIDS. It is commonly seen in late stage AIDS, and even when treated has the potential to
cause substantial loss of vision. CMV retinitis is also the most costly AIDS-related
opportunistic infection; the mean monthly cost of treatment has been estimated at $7,825. The
incidence of CMV retinitis has varied with changes in the therapeutic and prophylactic
strategies for AIDS and its complications. It has been on the decline in recent years related
to the increased use of highly active anti-retroviral therapy (HAART).
Other ocular complications of AIDS such as ocular toxoplasmosis, herpes zoster retinitis, and
pneumocystis choroidopathy occur less frequently than CMV retinitis and HIV retinopathy.
Their frequency has also changed over the course of the AIDS epidemic.
Because the epidemiology of AIDS is rapidly evolving, with HIV becoming more like a chronic
disease, new information is needed on the incidence and course of ocular complications. We
have little information about the effect of HAART therapy over time on changes in immune
status and the risk of ocular complications of AIDS. More information is also needed to
determine who is at risk for developing ocular complications of AIDS, and how treatment is
affecting their visual function, quality of life, and survival.
The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is prospective observational
study of patients with AIDS. Patients with a prior diagnosis of AIDS according to the 1993
Centers for Disease Control and Prevention (CDC) criteria with or without ocular
complications will be enrolled over a 4 year period. Approximately 2,000 patients will be
enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between
300 and 600 patients. Followup visits for patients without ocular complications will be
scheduled every 6 months. Followup visits for patients with ocular complications at baseline
or diagnosed during followup will be every 3 months. Followup data will include eye
examinations, fundus photographs, visual function testing, medical history, hematology and
serum chemistry, and collection of plasma and blood cells for banking. Analysis of banked
specimens will include HIV RNA levels and CMV DNA levels.
observational model: Cohort
time perspective: Prospective
measure: incidence of CMV retinitis, other ocular complications, mortality.
time frame: Until one year after the enrollment of the last patient.
measure: incidence of sequelae of AIDS-related eye disease (e.g., retinal detachments), incidence of complications of therapy, and long-term outcomes of ocular complications (e.g., visual function, quality of life).
time frame: Until one year after the enrollment of the last patient.
Laboratory studies will include hematology serum chemistry and lymphocyte subset analysis for
all patients. The amount of blood for hematology, serum chemistry, and lymphocyte subset
analysis is restricted to no more than a total of 17 mL per draw. Data existing on HIV viral
load analysis at the clinic will be collected. If HIV data are not available from medical
records within the visit time window, blood should be collected for local HIV viral load
determination.
study pop:
sampling method: Non-Probability Sample
criteria:
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Doug A Jabs, MD
role: Study Chair
affiliation: Icahn School of Medicine at Mount Sinai
facility:
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country: United States
citation: Jabs DA, Van Natta ML, Kempen JH, Reed Pavan P, Lim JI, Murphy RL, Hubbard LD. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2002 Jan;133(1):48-61. doi: 10.1016/s0002-9394(01)01322-8.
PMID: 11755839
citation: Kempen JH, Martin BK, Wu AW, Barron B, Thorne JE, Jabs DA; Studies of Ocular Complications of AIDS Researh Group. The effect of cytomegalovirus retinitis on the quality of life of patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2003 May;110(5):987-95. doi: 10.1016/S0161-6420(03)00089-7.
PMID: 12750102
citation: Jacobson MA, Maecker HT, Orr PL, D'Amico R, Van Natta M, Li XD, Pollard RB, Bredt BM; Adult AIDS Clinical Trials Group and the Studies of Ocular Complications of AIDS Research Group. Results of a cytomegalovirus (CMV)-specific CD8+/interferon- gamma+ cytokine flow cytometry assay correlate with clinical evidence of protective immunity in patients with AIDS with CMV retinitis. J Infect Dis. 2004 Apr 15;189(8):1362-73. doi: 10.1086/382964. Epub 2004 Mar 31.
PMID: 15073672
citation: Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 1. Retinitis progression. Ophthalmology. 2004 Dec;111(12):2224-31. doi: 10.1016/j.ophtha.2004.05.031.
PMID: 15582078
citation: Jabs DA, Van Natta ML, Thorne JE, Weinberg DV, Meredith TA, Kuppermann BD, Sepkowitz K, Li HK; Studies of Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 2. Second eye involvement and retinal detachment. Ophthalmology. 2004 Dec;111(12):2232-9. doi: 10.1016/j.ophtha.2004.05.028.
PMID: 15582079
citation: Weinberg DV, Holbrook JT, Hubbard LD, Davis MD, Jabs DA, Holland GN; Studies of Ocular Complications of AIDS Research Group. Clinician versus reading center assessment of cytomegalovirus retinitis lesion size. Ophthalmology. 2005 Apr;112(4):559-66. doi: 10.1016/j.ophtha.2004.11.027.
PMID: 15808244
citation: Jabs DA, Holbrook JT, Van Natta ML, Clark R, Jacobson MA, Kempen JH, Murphy RL; Studies of Ocular Complications of AIDS Research Group. Risk factors for mortality in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2005 May;112(5):771-9. doi: 10.1016/j.ophtha.2004.10.049.
PMID: 15878056
citation: Semba RD, Martin BK, Kempen JH, Thorne JE, Wu AW; Ocular Complications of AIDS Research Group. The impact of anemia on energy and physical functioning in individuals with AIDS. Arch Intern Med. 2005 Oct 24;165(19):2229-36. doi: 10.1001/archinte.165.19.2229.
PMID: 16246988
citation: Kempen JH, Min YI, Freeman WR, Holland GN, Friedberg DN, Dieterich DT, Jabs DA; Studies of Ocular Complications of AIDS Research Group. Risk of immune recovery uveitis in patients with AIDS and cytomegalovirus retinitis. Ophthalmology. 2006 Apr;113(4):684-94. doi: 10.1016/j.ophtha.2005.10.067.
PMID: 16581429
citation: Brown DM, Thorne JE, Foster GL, Duncan JL, Brune LM, Munana A, Meinert CL, Jabs DA. Factors affecting attrition in a longitudinal study of patients with AIDS. AIDS Care. 2006 Oct;18(7):821-9. doi: 10.1080/09540120500466747.
PMID: 16971294
citation: Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1432-40. doi: 10.1016/j.ophtha.2006.03.021. Epub 2006 Jun 12.
PMID: 16766032
citation: Thorne JE, Jabs DA, Kempen JH, Holbrook JT, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Causes of visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Ophthalmology. 2006 Aug;113(8):1441-5. doi: 10.1016/j.ophtha.2006.03.022. Epub 2006 Jun 15.
PMID: 16781775
citation: Shah KH, Holland GN, Yu F, Van Natta M, Nusinowitz S; Studies of Ocular Complications of AIDS (SOCA) Research Group. Contrast sensitivity and color vision in HIV-infected individuals without infectious retinopathy. Am J Ophthalmol. 2006 Aug;142(2):284-92. doi: 10.1016/j.ajo.2006.03.046.
PMID: 16876510
citation: Sinclair E, Tan QX, Sharp M, Girling V, Poon C, Natta MV, Jabs DA, Inokuma M, Maecker HT, Bredt B, Jacobson MA; Studies of Ocular Complications of AIDS Research Group. Protective immunity to cytomegalovirus (CMV) retinitis in AIDS is associated with CMV-specific T cells that express interferon- gamma and interleukin-2 and have a CD8+ cell early maturational phenotype. J Infect Dis. 2006 Dec 1;194(11):1537-46. doi: 10.1086/508997. Epub 2006 Oct 26.
PMID: 17083038
citation: Thorne JE, Holbrook JT, Jabs DA, Kempen JH, Nichols C, Meinert CL; Studies of Ocular Complications of AIDS Research Group. Effect of cytomegalovirus retinitis on the risk of visual acuity loss among patients with AIDS. Ophthalmology. 2007 Mar;114(3):591-8. doi: 10.1016/j.ophtha.2006.08.008. Epub 2006 Nov 22.
PMID: 17123624
citation: Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 1. Ocular diagnoses at enrollment. Ophthalmology. 2007 Apr;114(4):780-6. doi: 10.1016/j.ophtha.2006.11.008. Epub 2007 Jan 25.
PMID: 17258320
citation: Jabs DA, Van Natta ML, Holbrook JT, Kempen JH, Meinert CL, Davis MD; Studies of the Ocular Complications of AIDS Research Group. Longitudinal study of the ocular complications of AIDS: 2. Ocular examination results at enrollment. Ophthalmology. 2007 Apr;114(4):787-93. doi: 10.1016/j.ophtha.2006.07.065. Epub 2007 Jan 8.
PMID: 17210182
citation: Jacobson MA, Tan QX, Girling V, Poon C, Van Natta M, Jabs DA, Inokuma M, Maecker HT, Bredt B, Sinclair E; Studies of Ocular Complications of AIDS Research Group. Poor predictive value of cytomegalovirus (CMV)-specific T cell assays for the development of CMV retinitis in patients with AIDS. Clin Infect Dis. 2008 Feb 1;46(3):458-66. doi: 10.1086/525853.
PMID: 18173357
citation: Freeman WR, Van Natta ML, Jabs D, Sample PA, Sadun AA, Thorne J, Shah KH, Holland GN; SOCA Research Group. Vision function in HIV-infected individuals without retinitis: report of the Studies of Ocular Complications of AIDS Research Group. Am J Ophthalmol. 2008 Mar;145(3):453-462. doi: 10.1016/j.ajo.2007.10.013. Epub 2008 Jan 11.
PMID: 18191094
citation: Jabs DA. AIDS and ophthalmology, 2008. Arch Ophthalmol. 2008 Aug;126(8):1143-6. doi: 10.1001/archopht.126.8.1143. No abstract available.
PMID: 18695113
citation: Holland GN, Kappel PJ, Van Natta ML, Palella FJ, Lyon AT, Shah KH, Pavan PR, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association between abnormal contrast sensitivity and mortality among people with acquired immunodeficiency syndrome. Am J Ophthalmol. 2010 May;149(5):807-16. doi: 10.1016/j.ajo.2009.12.019.
PMID: 20399927
citation: Hendrickson SL, Jabs DA, Van Natta M, Lewis RA, Wallace DC, O'Brien SJ. Mitochondrial haplogroups are associated with risk of neuroretinal disorder in HIV-positive patients. J Acquir Immune Defic Syndr. 2010 Apr 1;53(4):451-5. doi: 10.1097/QAI.0b013e3181cb8319.
PMID: 20098332
citation: Sezgin E, Jabs DA, Hendrickson SL, Van Natta M, Zdanov A, Lewis RA, Smith MW, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on the development of cytomegalovirus retinitis in patients with AIDS. J Infect Dis. 2010 Aug 15;202(4):606-13. doi: 10.1086/654814.
PMID: 20617924
citation: Sezgin E, Hendrickson SL, Jabs DA, Van Natta ML, Lewis RA, Troyer JL, O'Brien SJ; SOCA Research Group. Effect of host genetics on incidence of HIV neuroretinal disorder in patients with AIDS. J Acquir Immune Defic Syndr. 2010 Aug;54(4):343-51. doi: 10.1097/QAI.0b013e3181deaf4d.
PMID: 20531015
citation: Puhan MA, Van Natta ML, Palella FJ, Addessi A, Meinert C; Ocular Complications of AIDS Research Group. Excess mortality in patients with AIDS in the era of highly active antiretroviral therapy: temporal changes and risk factors. Clin Infect Dis. 2010 Oct 15;51(8):947-56. doi: 10.1086/656415.
PMID: 20825306
citation: Jabs DA, Ahuja A, Van Natta M, Lyon A, Srivastava S, Gangaputra S; Studies of the Ocular Complications of AIDS Research Group. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: five-year outcomes. Ophthalmology. 2010 Nov;117(11):2152-61.e1-2. doi: 10.1016/j.ophtha.2010.03.031. Epub 2010 Jul 29.
PMID: 20673591
citation: Thorne JE, Van Natta ML, Jabs DA, Duncan JL, Srivastava SK; Studies of Ocular Complications of AIDS Research Group. Visual field loss in patients with cytomegalovirus retinitis. Ophthalmology. 2011 May;118(5):895-901. doi: 10.1016/j.ophtha.2010.09.017. Epub 2010 Dec 13.
PMID: 21146225
citation: Sezgin E, van Natta ML, Ahuja A, Lyon A, Srivastava S, Troyer JL, O'Brien SJ, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Association of host genetic risk factors with the course of cytomegalovirus retinitis in patients infected with human immunodeficiency virus. Am J Ophthalmol. 2011 Jun;151(6):999-1006.e4. doi: 10.1016/j.ajo.2010.11.029. Epub 2011 Mar 10.
PMID: 21396623
citation: Holbrook JT, Colvin R, van Natta ML, Thorne JE, Bardsley M, Jabs DA; Studies of Ocular Complications of AIDS (SOCA) Research Group. Evaluation of the United States public health service guidelines for discontinuation of anticytomegalovirus therapy after immune recovery in patients with cytomegalovirus retinitis. Am J Ophthalmol. 2011 Oct;152(4):628-637.e1. doi: 10.1016/j.ajo.2011.04.007. Epub 2011 Jul 13.
PMID: 21742304
citation: Puhan MA, Ahuja A, Van Natta ML, Ackatz LE, Meinert C; Studies of Ocular Complications of AIDS Research Group. Interviewer versus self-administered health-related quality of life questionnaires - does it matter? Health Qual Life Outcomes. 2011 May 10;9:30. doi: 10.1186/1477-7525-9-30.
PMID: 21554737
citation: Gangaputra S, Pak JW, Peng Q, Hubbard LD, Thayer D, Krason Z, Joyce J, Danis RP; Studies of the Ocular Complications of AIDS Research Group. Transition from film to digital fundus photography in the Longitudinal Studies of the Ocular Complications of AIDS. Retina. 2012 Mar;32(3):600-5. doi: 10.1097/IAE.0b013e318221592f.
PMID: 21857393
citation: Gangaputra S, Kalyani PS, Fawzi AA, Van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with disease-associated factors and mortality. Am J Ophthalmol. 2012 Mar;153(3):434-444.e1. doi: 10.1016/j.ajo.2011.08.028. Epub 2011 Oct 22.
PMID: 22019225
citation: Kalyani PS, Fawzi AA, Gangaputra S, van Natta ML, Hubbard LD, Danis RP, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with visual function. Am J Ophthalmol. 2012 Mar;153(3):428-433.e1. doi: 10.1016/j.ajo.2011.08.027. Epub 2011 Oct 22.
PMID: 22019221
citation: Sugar EA, Jabs DA, Ahuja A, Thorne JE, Danis RP, Meinert CL; Studies of the Ocular Complications of AIDS Research Group. Incidence of cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol. 2012 Jun;153(6):1016-24.e5. doi: 10.1016/j.ajo.2011.11.014. Epub 2012 Feb 4.
PMID: 22310076
citation: Limou S, Delaneau O, van Manen D, An P, Sezgin E, Le Clerc S, Coulonges C, Troyer JL, Veldink JH, van den Berg LH, Spadoni JL, Taing L, Labib T, Montes M, Delfraissy JF, Schachter F, O'Brien SJ, Buchbinder S, van Natta ML, Jabs DA, Froguel P, Schuitemaker H, Winkler CA, Zagury JF. Multicohort genomewide association study reveals a new signal of protection against HIV-1 acquisition. J Infect Dis. 2012 Apr 1;205(7):1155-62. doi: 10.1093/infdis/jis028. Epub 2012 Feb 23.
PMID: 22362864
citation: Kalyani PS, Holland GN, Fawzi AA, Arantes TE, Yu F, Sadun AA; Studies of the Ocular Complications of AIDS Research Group. Association between retinal nerve fiber layer thickness and abnormalities of vision in people with human immunodeficiency virus infection. Am J Ophthalmol. 2012 Apr;153(4):734-42, 742.e1. doi: 10.1016/j.ajo.2011.09.019. Epub 2012 Jan 15.
PMID: 22245459
citation: Branch AD, Van Natta ML, Vachon ML, Dieterich DT, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Mortality in hepatitis C virus-infected patients with a diagnosis of AIDS in the era of combination antiretroviral therapy. Clin Infect Dis. 2012 Jul;55(1):137-44. doi: 10.1093/cid/cis404. Epub 2012 Apr 24.
PMID: 22534149
citation: Kempen JH, Sugar EA, Lyon AT, Lewis RA, Jabs DA, Heinemann MH, Dunn JP; Studies of Ocular Complications of AIDS Research Group. Risk of cataract in persons with cytomegalovirus retinitis and the acquired immune deficiency syndrome. Ophthalmology. 2012 Nov;119(11):2343-50. doi: 10.1016/j.ophtha.2012.05.044. Epub 2012 Jul 30.
PMID: 22853972
citation: Kozak I, Ahuja A, Gangaputra S, Van Natta ML, Thorne JE, Freeman WR. Optic nerve head morphology and visual field function in patients with AIDS and without infectious retinitis. Ocul Immunol Inflamm. 2012 Oct;20(5):342-8. doi: 10.3109/09273948.2012.694552. Epub 2012 Jun 14.
PMID: 22697270
citation: Gangaputra S, Drye L, Vaidya V, Thorne JE, Jabs DA, Lyon AT; Studies of the Ocular Complications of AIDS (SOCA) Research Group. Non-cytomegalovirus ocular opportunistic infections in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2013 Feb;155(2):206-212.e5. doi: 10.1016/j.ajo.2012.07.019. Epub 2012 Oct 12.
PMID: 23068916
citation: Jabs DA, Ahuja A, Van Natta M, Dunn JP, Yeh S; Studies of the Ocular Complications of AIDS Research Group. Comparison of treatment regimens for cytomegalovirus retinitis in patients with AIDS in the era of highly active antiretroviral therapy. Ophthalmology. 2013 Jun;120(6):1262-70. doi: 10.1016/j.ophtha.2012.11.023. Epub 2013 Feb 16.
PMID: 23419804
citation: Krauskopf K, Van Natta ML, Danis RP, Gangaputra S, Ackatz L, Addessi A, Federman AD, Branch AD, Meinert CL, Jabs DA; Studies of the Ocular Complications of AIDS Research Group. Correlates of hypertension in patients with AIDS in the era of highly active antiretroviral therapy. J Int Assoc Provid AIDS Care. 2013 Sep-Oct;12(5):325-33. doi: 10.1177/2325957413491432.
PMID: 23764503
citation: Branch AD, Drye LT, Van Natta ML, Sezgin E, Fishman SL, Dieterich DT, Meinert CL, Jabs DA. Evaluation of hepatitis C virus as a risk factor for HIV-associated neuroretinal disorder. Clin Infect Dis. 2013 Dec;57(11):1618-25. doi: 10.1093/cid/cit550. Epub 2013 Sep 30.
PMID: 24081683
citation: Serrano-Villar S, Sainz T, Lee SA, Hunt PW, Sinclair E, Shacklett BL, Ferre AL, Hayes TL, Somsouk M, Hsue PY, Van Natta ML, Meinert CL, Lederman MM, Hatano H, Jain V, Huang Y, Hecht FM, Martin JN, McCune JM, Moreno S, Deeks SG. HIV-infected individuals with low CD4/CD8 ratio despite effective antiretroviral therapy exhibit altered T cell subsets, heightened CD8+ T cell activation, and increased risk of non-AIDS morbidity and mortality. PLoS Pathog. 2014 May 15;10(5):e1004078. doi: 10.1371/journal.ppat.1004078. eCollection 2014 May.
PMID: 24831517
citation: Hunt PW, Sinclair E, Rodriguez B, Shive C, Clagett B, Funderburg N, Robinson J, Huang Y, Epling L, Martin JN, Deeks SG, Meinert CL, Van Natta ML, Jabs DA, Lederman MM. Gut epithelial barrier dysfunction and innate immune activation predict mortality in treated HIV infection. J Infect Dis. 2014 Oct 15;210(8):1228-38. doi: 10.1093/infdis/jiu238. Epub 2014 Apr 21.
PMID: 24755434
citation: Lee SA, Sinclair E, Jain V, Huang Y, Epling L, Van Natta M, Meinert CL, Martin JN, McCune JM, Deeks SG, Lederman MM, Hecht FM, Hunt PW. Low proportions of CD28- CD8+ T cells expressing CD57 can be reversed by early ART initiation and predict mortality in treated HIV infection. J Infect Dis. 2014 Aug 1;210(3):374-82. doi: 10.1093/infdis/jiu109. Epub 2014 Feb 28.
PMID: 24585893
citation: Kozak I, Vaidya V, Van Natta ML, Pak JW, May KP, Thorne JE; Studies of the Ocular Complications of AIDS Research Group. The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis. Invest Ophthalmol Vis Sci. 2014 Jun 12;55(7):4304-12. doi: 10.1167/iovs.14-14479.
PMID: 24925880
citation: Kempen JH, Sugar EA, Varma R, Dunn JP, Heinemann MH, Jabs DA, Lyon AT, Lewis RA; Studies of Ocular Complications of AIDS Research Group. Risk of cataract among subjects with acquired immune deficiency syndrome free of ocular opportunistic infections. Ophthalmology. 2014 Dec;121(12):2317-24. doi: 10.1016/j.ophtha.2014.06.014. Epub 2014 Aug 8.
PMID: 25109932
citation: Jabs DA, Drye L, Van Natta ML, Thorne JE, Holland GN; Studies of the Ocular Complications of AIDS Research Group. Incidence and long-term outcomes of the human immunodeficiency virus neuroretinal disorder in patients with AIDS. Ophthalmology. 2015 Apr;122(4):760-8. doi: 10.1016/j.ophtha.2014.11.009. Epub 2015 Jan 16.
PMID: 25600199
citation: Jabs DA, Van Natta ML, Sezgin E, Pak JW, Danis R; Studies of the Ocular Complications of AIDS Research Group. Prevalence of intermediate-stage age-related macular degeneration in patients with acquired immunodeficiency syndrome. Am J Ophthalmol. 2015 Jun;159(6):1115-1122.e1. doi: 10.1016/j.ajo.2015.01.037. Epub 2015 Mar 11.
PMID: 25769246
citation: Jabs DA, Ahuja A, Van Natta ML, Lyon AT, Yeh S, Danis R; Studies of the Ocular Complications of AIDS Research Group. Long-term Outcomes of Cytomegalovirus Retinitis in the Era of Modern Antiretroviral Therapy: Results from a United States Cohort. Ophthalmology. 2015 Jul;122(7):1452-63. doi: 10.1016/j.ophtha.2015.02.033. Epub 2015 Apr 17.
PMID: 25892019
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins Bloomberg School of Public Health
investigator full name: Curtis Meinert
investigator title: Professor
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Cytomegalovirus Retinitis
mesh term: Retinitis
mesh term: Immunologic Deficiency Syndromes
|
NCT0000xxxx/NCT00000169.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000169</url>
</required_header>
<id_info>
<org_study_id>NEI-72</org_study_id>
<nct_id>NCT00000169</nct_id>
</id_info>
<brief_title>The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Eye Institute (NEI)</source>
<brief_summary>
<textblock>
To compare and contrast normal eye growth, ocular component development, and refractive error
development in Hispanic, African-American, and Asian schoolchildren with what happens in
Caucasian children from the Orinda Longitudinal Study of Myopia.

To investigate risk factors for the development of myopia.

To conduct DNA-based studies on nearsighted children and their families.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
The Orinda Longitudinal Study of Myopia (OLSM) was started in 1989 to investigate normal eye
growth and the development of myopia in over 1,200 school-aged children to date. Beginning in
1997, three parallel study phases are being conducted. Phase 1 investigates additional
factors that may predict the onset of juvenile myopia (accommodative function, peripheral
refractive error, intraocular pressure, and school achievement). Phase 2 compares and
contrasts the optical ocular components and refractive error profiles of other ethnic groups
with the predominantly Caucasian Orinda database. Phase 3 conducts DNA-based studies on the
prevalent OLSM myopes and their families to use these phenotypically well-characterized
children and a panel of candidate genes to look for evidence of genetic factors. In parallel
with the candidate gene association, family material is used in an allele sharing approach to
identify loci using highly variable, PCR-based markers.

In Phase 1 we continue to examine Orinda Union School District children in grades 1 through 8
(ages 6 through 14 years) annually. The measurement of accommodative response, accommodative
lag, phoria, response AC/A ratio, peripheral refractive error, and intraocular pressure will
be added to the existing protocol, and photokeratoscopy and two measures of tonic
accommodation will be eliminated to minimize respondent burden. Parents of children in the
study will be contacted for their permission to release school achievement data (Iowa Test of
Basic Skills).

Phase 2 adds a major component by adding three clinical centers to assess the influence of
ethnicity on normal ocular and refractive error development. Children in these three are
examined annually with initial enrollment in all grades from 1 through 8 using the revised
OLSM protocol as described above.

Increased prevalence of myopia among children of myopic parents, twin studies, segregation
analysis, and our own preliminary analyses from the OLSM support a genetic etiologic
component for myopia. In phase 3, we use the phenotypic characterization of children in the
Orinda Longitudinal Study of Myopia to identify prevalent cases of myopia and their families.
These well-defined phenotypic myopes and non-myopic siblings and their parents are being
explored, seeking to develop a panel of candidate genes for myopia and to conduct an allele
sharing analysis in these families

The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study is
a multi-center, observational investigation of ocular development and refractive error
development in schoolchildren. It adds three clinical centers to the Orinda Longitudinal
Study of Myopia (OLSM), begun in 1989, specifically to describe normal ocular growth in
children ages 6 to 14 years, and to develop the ability to predict juvenile onset myopia
before it is clinically evident. In addition to the more than 1,300 predominantly Caucasian
children enrolled in the OLSM, three additional clinical sites enroll African-American,
Hispanic, and Asian children. The children are examined annually for at least four years.
Examinations include visual acuity, refraction by a variety of methods (cycloplegic
autorefraction being the primary outcome measure), cover test at distance and near,
accommodative response assessment with the autorefractor, response AC/A ratio measurement,
videophakometry, peripheral refraction, and A-scan ultrasonography.

Patients are examined at 4 clinical centers. The clinical centers have enrolled 3,493
patients as of April 28, 1999.
</textblock>
</detailed_description>
<overall_status>Unknown status</overall_status>
<last_known_status>Recruiting</last_known_status>
<start_date>April 1999</start_date>
<study_type>Observational</study_type>
<has_expanded_access>No</has_expanded_access>
<condition>Myopia</condition>
<eligibility>
<criteria>
<textblock>
Children were eligible if they were enrolled in the first through eighth grades in selected
schools in Eutaw, Alabama; Houston, Texas; Orinda, California; or Irvine, California in the
1997-98 academic year and in the first grade only in Eutaw, Houston, and Irvine in the
1998-99 academic year.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>6 Years</minimum_age>
<maximum_age>14 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Lisa A. Jones, Ph.D.</last_name>
<phone>1-614-292-7097</phone>
<email>[email protected]</email>
</overall_contact>
<location>
<facility>
<name>West Alabama Health Services, Inc.</name>
<address>
<city>Eutaw</city>
<state>Alabama</state>
<zip>35462</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Sandral Hullett, MD, et al</last_name>
<phone>205-372-3674</phone>
<email>[email protected]</email>
</contact>
</location>
<location>
<facility>
<name>Southern California College of Optometry</name>
<address>
<city>Fullerton</city>
<state>California</state>
<zip>92831</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Julie A. Yu, OD</last_name>
<phone>714-992-7806</phone>
<email>[email protected]</email>
</contact>
</location>
<location>
<facility>
<name>University of Houston, College of Optometry</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77204-2020</zip>
<country>United States</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Ruth E. Manny, OD PhD</last_name>
<phone>713-743-1944</phone>
<email>[email protected]</email>
</contact>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Mutti DO, Zadnik K, Adams AJ. A video technique for phakometry of the human crystalline lens. Invest Ophthalmol Vis Sci. 1992 Apr;33(5):1771-82.</citation>
<PMID>1559777</PMID>
</reference>
<reference>
<citation>Zadnik K, Mutti DO, Adams AJ. The repeatability of measurement of the ocular components. Invest Ophthalmol Vis Sci. 1992 Jun;33(7):2325-33.</citation>
<PMID>1607244</PMID>
</reference>
<reference>
<citation>Walline JJ, Zadnik K, Mutti DO. Validity of surveys reporting myopia, astigmatism, and presbyopia. Optom Vis Sci. 1996 Jun;73(6):376-81. doi: 10.1097/00006324-199606000-00004.</citation>
<PMID>8807648</PMID>
</reference>
<reference>
<citation>Zadnik K, Mutti DO, Friedman NE, Adams AJ. Initial cross-sectional results from the Orinda Longitudinal Study of Myopia. Optom Vis Sci. 1993 Sep;70(9):750-8. doi: 10.1097/00006324-199309000-00012.</citation>
<PMID>8233371</PMID>
</reference>
<reference>
<citation>Zadnik K, Satariano WA, Mutti DO, Sholtz RI, Adams AJ. The effect of parental history of myopia on children's eye size. JAMA. 1994 May 4;271(17):1323-7.</citation>
<PMID>8158816</PMID>
</reference>
<reference>
<citation>Zadnik K, Friedman NE, Mutti DO. Repeatability of corneal topography: the "corneal field". J Refract Surg. 1995 Mar-Apr;11(2):119-25. doi: 10.3928/1081-597X-19950301-12. Erratum In: J Refract Surg 1995 May-Jun;11(3):164.</citation>
<PMID>7634141</PMID>
</reference>
<reference>
<citation>Mutti DO, Zadnik K, Adams AJ. The equivalent refractive index of the crystalline lens in childhood. Vision Res. 1995 Jun;35(11):1565-73. doi: 10.1016/0042-6989(94)00262-k.</citation>
<PMID>7667914</PMID>
</reference>
<reference>
<citation>Zadnik K, Mutti DO, Fusaro RE, Adams AJ. Longitudinal evidence of crystalline lens thinning in children. Invest Ophthalmol Vis Sci. 1995 Jul;36(8):1581-7.</citation>
<PMID>7601639</PMID>
</reference>
<reference>
<citation>Friedman NE, Zadnik K, Mutti DO, Fusaro RE. Quantifying corneal toricity from videokeratography with Fourier analysis. J Refract Surg. 1996 Jan-Feb;12(1):108-13. doi: 10.3928/1081-597X-19960101-20.</citation>
<PMID>8963798</PMID>
</reference>
<reference>
<citation>Friedman NE, Mutti DO, Zadnik K. Corneal changes in schoolchildren. Optom Vis Sci. 1996 Aug;73(8):552-7. doi: 10.1097/00006324-199608000-00006.</citation>
<PMID>8869987</PMID>
</reference>
<reference>
<citation>Mutti DO, Zadnik K, Fusaro RE, Friedman NE, Sholtz RI, Adams AJ. Optical and structural development of the crystalline lens in childhood. Invest Ophthalmol Vis Sci. 1998 Jan;39(1):120-33.</citation>
<PMID>9430553</PMID>
</reference>
<reference>
<citation>Kleinstein RN, Mutti DO, Manny RE, Shin JA, Zadnik K. Cycloplegia in African-American children. Optom Vis Sci. 1999 Feb;76(2):102-7. doi: 10.1097/00006324-199902000-00017.</citation>
<PMID>10082056</PMID>
</reference>
<reference>
<citation>Shin JA, Manny RE, Kleinstein RN, Mutti DO, Zadnik K. Short-term repeatability of hand-held keratometry measurements. Optom Vis Sci. 1999 Apr;76(4):247-53. doi: 10.1097/00006324-199904000-00029.</citation>
<PMID>10333188</PMID>
</reference>
<reference>
<citation>Zadnik K, Mutti DO, Kim HS, Jones LA, Qiu PH, Moeschberger ML. Tonic accommodation, age, and refractive error in children. Invest Ophthalmol Vis Sci. 1999 May;40(6):1050-60.</citation>
<PMID>10235538</PMID>
</reference>
<reference>
<citation>Zadnik K, Mutti DO, Friedman NE, Qualley PA, Jones LA, Qui P, Kim HS, Hsu JC, Moeschberger ML. Ocular predictors of the onset of juvenile myopia. Invest Ophthalmol Vis Sci. 1999 Aug;40(9):1936-43.</citation>
<PMID>10440246</PMID>
</reference>
<verification_date>June 2001</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Myopia</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000169
org study id: NEI-72
nct id: NCT00000169
lead sponsor:
To compare and contrast normal eye growth, ocular component development, and refractive error
development in Hispanic, African-American, and Asian schoolchildren with what happens in
Caucasian children from the Orinda Longitudinal Study of Myopia.
To investigate risk factors for the development of myopia.
To conduct DNA-based studies on nearsighted children and their families.
The Orinda Longitudinal Study of Myopia (OLSM) was started in 1989 to investigate normal eye
growth and the development of myopia in over 1,200 school-aged children to date. Beginning in
1997, three parallel study phases are being conducted. Phase 1 investigates additional
factors that may predict the onset of juvenile myopia (accommodative function, peripheral
refractive error, intraocular pressure, and school achievement). Phase 2 compares and
contrasts the optical ocular components and refractive error profiles of other ethnic groups
with the predominantly Caucasian Orinda database. Phase 3 conducts DNA-based studies on the
prevalent OLSM myopes and their families to use these phenotypically well-characterized
children and a panel of candidate genes to look for evidence of genetic factors. In parallel
with the candidate gene association, family material is used in an allele sharing approach to
identify loci using highly variable, PCR-based markers.
In Phase 1 we continue to examine Orinda Union School District children in grades 1 through 8
(ages 6 through 14 years) annually. The measurement of accommodative response, accommodative
lag, phoria, response AC/A ratio, peripheral refractive error, and intraocular pressure will
be added to the existing protocol, and photokeratoscopy and two measures of tonic
accommodation will be eliminated to minimize respondent burden. Parents of children in the
study will be contacted for their permission to release school achievement data (Iowa Test of
Basic Skills).
Phase 2 adds a major component by adding three clinical centers to assess the influence of
ethnicity on normal ocular and refractive error development. Children in these three are
examined annually with initial enrollment in all grades from 1 through 8 using the revised
OLSM protocol as described above.
Increased prevalence of myopia among children of myopic parents, twin studies, segregation
analysis, and our own preliminary analyses from the OLSM support a genetic etiologic
component for myopia. In phase 3, we use the phenotypic characterization of children in the
Orinda Longitudinal Study of Myopia to identify prevalent cases of myopia and their families.
These well-defined phenotypic myopes and non-myopic siblings and their parents are being
explored, seeking to develop a panel of candidate genes for myopia and to conduct an allele
sharing analysis in these families
The Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error (CLEERE) Study is
a multi-center, observational investigation of ocular development and refractive error
development in schoolchildren. It adds three clinical centers to the Orinda Longitudinal
Study of Myopia (OLSM), begun in 1989, specifically to describe normal ocular growth in
children ages 6 to 14 years, and to develop the ability to predict juvenile onset myopia
before it is clinically evident. In addition to the more than 1,300 predominantly Caucasian
children enrolled in the OLSM, three additional clinical sites enroll African-American,
Hispanic, and Asian children. The children are examined annually for at least four years.
Examinations include visual acuity, refraction by a variety of methods (cycloplegic
autorefraction being the primary outcome measure), cover test at distance and near,
accommodative response assessment with the autorefractor, response AC/A ratio measurement,
videophakometry, peripheral refraction, and A-scan ultrasonography.
Patients are examined at 4 clinical centers. The clinical centers have enrolled 3,493
patients as of April 28, 1999.
criteria:
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa A. Jones, Ph.D.
phone: 1-614-292-7097
email: [email protected]
facility:
status: Recruiting
contact:
facility:
status: Recruiting
contact:
facility:
status: Recruiting
contact:
country: United States
citation: Mutti DO, Zadnik K, Adams AJ. A video technique for phakometry of the human crystalline lens. Invest Ophthalmol Vis Sci. 1992 Apr;33(5):1771-82.
PMID: 1559777
citation: Zadnik K, Mutti DO, Adams AJ. The repeatability of measurement of the ocular components. Invest Ophthalmol Vis Sci. 1992 Jun;33(7):2325-33.
PMID: 1607244
citation: Walline JJ, Zadnik K, Mutti DO. Validity of surveys reporting myopia, astigmatism, and presbyopia. Optom Vis Sci. 1996 Jun;73(6):376-81. doi: 10.1097/00006324-199606000-00004.
PMID: 8807648
citation: Zadnik K, Mutti DO, Friedman NE, Adams AJ. Initial cross-sectional results from the Orinda Longitudinal Study of Myopia. Optom Vis Sci. 1993 Sep;70(9):750-8. doi: 10.1097/00006324-199309000-00012.
PMID: 8233371
citation: Zadnik K, Satariano WA, Mutti DO, Sholtz RI, Adams AJ. The effect of parental history of myopia on children's eye size. JAMA. 1994 May 4;271(17):1323-7.
PMID: 8158816
citation: Zadnik K, Friedman NE, Mutti DO. Repeatability of corneal topography: the "corneal field". J Refract Surg. 1995 Mar-Apr;11(2):119-25. doi: 10.3928/1081-597X-19950301-12. Erratum In: J Refract Surg 1995 May-Jun;11(3):164.
PMID: 7634141
citation: Mutti DO, Zadnik K, Adams AJ. The equivalent refractive index of the crystalline lens in childhood. Vision Res. 1995 Jun;35(11):1565-73. doi: 10.1016/0042-6989(94)00262-k.
PMID: 7667914
citation: Zadnik K, Mutti DO, Fusaro RE, Adams AJ. Longitudinal evidence of crystalline lens thinning in children. Invest Ophthalmol Vis Sci. 1995 Jul;36(8):1581-7.
PMID: 7601639
citation: Friedman NE, Zadnik K, Mutti DO, Fusaro RE. Quantifying corneal toricity from videokeratography with Fourier analysis. J Refract Surg. 1996 Jan-Feb;12(1):108-13. doi: 10.3928/1081-597X-19960101-20.
PMID: 8963798
citation: Friedman NE, Mutti DO, Zadnik K. Corneal changes in schoolchildren. Optom Vis Sci. 1996 Aug;73(8):552-7. doi: 10.1097/00006324-199608000-00006.
PMID: 8869987
citation: Mutti DO, Zadnik K, Fusaro RE, Friedman NE, Sholtz RI, Adams AJ. Optical and structural development of the crystalline lens in childhood. Invest Ophthalmol Vis Sci. 1998 Jan;39(1):120-33.
PMID: 9430553
citation: Kleinstein RN, Mutti DO, Manny RE, Shin JA, Zadnik K. Cycloplegia in African-American children. Optom Vis Sci. 1999 Feb;76(2):102-7. doi: 10.1097/00006324-199902000-00017.
PMID: 10082056
citation: Shin JA, Manny RE, Kleinstein RN, Mutti DO, Zadnik K. Short-term repeatability of hand-held keratometry measurements. Optom Vis Sci. 1999 Apr;76(4):247-53. doi: 10.1097/00006324-199904000-00029.
PMID: 10333188
citation: Zadnik K, Mutti DO, Kim HS, Jones LA, Qiu PH, Moeschberger ML. Tonic accommodation, age, and refractive error in children. Invest Ophthalmol Vis Sci. 1999 May;40(6):1050-60.
PMID: 10235538
citation: Zadnik K, Mutti DO, Friedman NE, Qualley PA, Jones LA, Qui P, Kim HS, Hsu JC, Moeschberger ML. Ocular predictors of the onset of juvenile myopia. Invest Ophthalmol Vis Sci. 1999 Aug;40(9):1936-43.
PMID: 10440246
mesh term: Myopia
|
NCT0000xxxx/NCT00000170.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000170</url>
</required_header>
<id_info>
<org_study_id>NEI-73</org_study_id>
<secondary_id>2U10EY011751</secondary_id>
<secondary_id>5U10EY011751</secondary_id>
<nct_id>NCT00000170</nct_id>
</id_info>
<brief_title>Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia</brief_title>
<official_title>Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia</official_title>
<sponsors>
<lead_sponsor>
<agency>Jaeb Center for Health Research</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Eye Institute (NEI)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Jaeb Center for Health Research</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
- To determine whether the success rate with drug treatment (atropine) of amblyopia due to
strabismus or anisometropia in patients less than 7 years old is equivalent to the
success rate with occlusion (patching) therapy

- To develop more precise estimates of the success rates of amblyopia treatment

- To identify factors that may be associated with successful treatment of amblyopia

- To collect data on the course of treated amblyopia to provide more precise estimates of
treatment effects than are now available

Extended Follow up of Study Patients

- Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15
years in patients diagnosed with amblyopia before age 7 years.

- Secondary: To determine whether the long-term visual acuity outcome at age 10 years and
at age 15 years differs between patients who received patching followed by best clinical
care and patients who received atropine followed by best clinical care
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often
persists in adulthood. It is reported to be the leading cause of vision loss in one eye in
the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating
that both improved means of detection and treatment are needed.

Most of the available data on the natural history of amblyopia and success rates of its
treatment with either patching or drug therapy are retrospective and uncontrolled. Despite
the common occurrence of amblyopia, there is little quality data on treatment of this
condition. Thus, there is much to be learned about the course of treated amblyopia, to
provide more precise estimates of success rates and to identify factors that may be
associated with successful and unsuccessful treatment.

Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the
sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike
of wearing a patch for visual, skin irritation, and social/psychological reasons. There is
evidence that compliance may be one of, if not, the most important determinant of success of
amblyopia therapy.

An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the
pupils and blurs the image seen by the sound eye, has been known for almost a century. This
method has been widely used for the management of occlusion treatment failures and for
maintenance therapy. However, it has seen little use as a primary treatment for amblyopia.
Clinical experience has found that it has a high acceptability to patients and parents, and
hence high compliance. In addition to its acceptability, pharmacologic therapy has the known
advantage over occlusion of providing a wider visual field with both eyes, which may have
safety and other functional implications. There is also clinical and laboratory evidence
suggesting that drug therapy may maintain and improve the ability to see with both eyes
(binocularity).

Available data suggest that the success rate with drug therapy is as good as, if not better
than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If
this is true, for many children with amblyopia, drug therapy may be the preferred initial
therapy since it appears to be more readily accepted by the children and parents. Despite
data to support the use of drug therapy as a primary therapy for amblyopia, it has gained
only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes
from occlusion therapy and drug therapy is justified in order to determine if new practice
guidelines for treatment of amblyopia are needed.

Regardless of whether the trial determines that one therapeutic approach is better than the
other, the data that are collected will provide valuable information about the course of
amblyopia treatment that is not presently available. The study also is expected to provide
data that will help to determine whether factors such as age, refractive status, cause of
amblyopia, or fixation pattern should be considered in determining which procedure is best
for a given patient.

Extended Follow-up of Study Patients

The extended follow up study consists of annual visits prior to age 10, followed by a visit
at age 10 years and a visit at age 15 years. There is no amblyopia treatment that is required
during the extended follow up period.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>April 1999</start_date>
<completion_date type="Actual">August 2013</completion_date>
<primary_completion_date type="Actual">November 2001</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Visual acuity in the amblyopic eye</measure>
<time_frame>6 months</time_frame>
</primary_outcome>
<secondary_outcome>
<measure>Visual acuity in the amblyopic eye</measure>
<time_frame>24 months</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years</measure>
<time_frame>age 10 years and age 15 years</time_frame>
</secondary_outcome>
<secondary_outcome>
<measure>Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care</measure>
<time_frame>age 10 years and age 15 years</time_frame>
</secondary_outcome>
<number_of_arms>2</number_of_arms>
<enrollment type="Actual">419</enrollment>
<condition>Amblyopia</condition>
<arm_group>
<arm_group_label>Patching</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
</arm_group>
<arm_group>
<arm_group_label>Atropine</arm_group_label>
<arm_group_type>Active Comparator</arm_group_type>
<description>Atropine</description>
</arm_group>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Atropine</intervention_name>
<description>Atropine</description>
<arm_group_label>Atropine</arm_group_label>
</intervention>
<intervention>
<intervention_type>Device</intervention_type>
<intervention_name>Eye Patch</intervention_name>
<description>Patching</description>
<arm_group_label>Patching</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients must be 7 years old or younger with amblyopia due to strabismus or
anisometropia

- Visual acuity in the amblyopic eye must be between 20/40 and 20/100

- Visual acuity in the sound eye or 20/40 or better

- At least 3 lines of acuity difference between the two eyes

Exclusion Criteria:

- More than two months of amblyopia therapy in the past two years

- Myopia (more than -0.50 D)
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>6 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Michael X. Repka, M.D.</last_name>
<role>Study Chair</role>
<affiliation>Wilmer Eye Institute</affiliation>
</overall_official>
<location>
<facility>
<name>Wilmer Eye Institute</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287-9028</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.nei.nih.gov/news/pressreleases/031302.asp</url>
<description>ATS Press Release March 13, 2002</description>
</link>
<reference>
<citation>Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.</citation>
<PMID>11879129</PMID>
</reference>
<reference>
<citation>Pediatric Eye Disease Investigator Group. The clinical profile of moderate amblyopia in children younger than 7 years. Arch Ophthalmol. 2002 Mar;120(3):281-7.</citation>
<PMID>11879130</PMID>
</reference>
<reference>
<citation>Cole SR, Beck RW, Moke PS, Celano MP, Drews CD, Repka MX, Holmes JM, Birch EE, Kraker RT, Kip KE; Pediatric Eye Disease Investigator Group. The Amblyopia Treatment Index. J AAPOS. 2001 Aug;5(4):250-4. doi: 10.1067/mpa.2001.117097.</citation>
<PMID>11507585</PMID>
</reference>
<reference>
<citation>Holmes JM, Beck RW, Repka MX, Leske DA, Kraker RT, Blair RC, Moke PS, Birch EE, Saunders RA, Hertle RW, Quinn GE, Simons KA, Miller JM; Pediatric Eye Disease Investigator Group. The amblyopia treatment study visual acuity testing protocol. Arch Ophthalmol. 2001 Sep;119(9):1345-53. doi: 10.1001/archopht.119.9.1345.</citation>
<PMID>11545641</PMID>
</reference>
<reference>
<citation>Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age, cause of amblyopia, depth of amblyopia, and other factors. Ophthalmology. 2003 Aug;110(8):1632-7; discussion 1637-8. doi: 10.1016/S0161-6420(03)00500-1.</citation>
<PMID>12917184</PMID>
</reference>
<reference>
<citation>Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):630-9. doi: 10.1016/s0002-9394(03)00458-6.</citation>
<PMID>14516802</PMID>
</reference>
<reference>
<citation>Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with patching in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):620-9. doi: 10.1016/s0002-9394(03)00392-1.</citation>
<PMID>14516801</PMID>
</reference>
<reference>
<citation>Holmes JM, Beck RW, Kraker RT, Cole SR, Repka MX, Birch EE, Felius J, Christiansen SP, Coats DK, Kulp MT; Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.</citation>
<PMID>14609923</PMID>
</reference>
<reference>
<citation>Repka MX, Wallace DK, Beck RW, Kraker RT, Birch EE, Cotter SA, Donahue S, Everett DF, Hertle RW, Holmes JM, Quinn GE, Scheiman MM, Weakley DR; Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. doi: 10.1001/archopht.123.2.149.</citation>
<PMID>15710809</PMID>
</reference>
<reference>
<citation>Repka MX, Holmes JM, Melia BM, Beck RW, Gearinger MD, Tamkins SM, Wheeler DT; Pediatric Eye Disease Investigator Group. The effect of amblyopia therapy on ocular alignment. J AAPOS. 2005 Dec;9(6):542-5. doi: 10.1016/j.jaapos.2005.07.009.</citation>
<PMID>16414520</PMID>
</reference>
<reference>
<citation>Repka MX, Melia M, Eibschitz-Tsimhoni M, London R, Magoon E; Pediatric Eye Disease Investigator Group. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS. 2007 Jun;11(3):300-2. doi: 10.1016/j.jaapos.2006.09.017.</citation>
<PMID>17572346</PMID>
</reference>
<reference>
<citation>Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Beck RW, Holmes JM, Cotter SA, Birch EE, Astle WF, Chandler DL, Felius J, Arnold RW, Tien DR, Glaser SR. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol. 2008 Aug;126(8):1039-44. doi: 10.1001/archopht.126.8.1039.</citation>
<PMID>18695096</PMID>
</reference>
<reference>
<citation>Repka MX, Kraker RT, Beck RW, Cotter SA, Holmes JM, Arnold RW, Astle WF, Sala NA, Tien DR; Pediatric Eye Disease Investigator Group. Monocular oral reading performance after amblyopia treatment in children. Am J Ophthalmol. 2008 Dec;146(6):942-7. doi: 10.1016/j.ajo.2008.06.022. Epub 2008 Aug 16.</citation>
<PMID>18708179</PMID>
</reference>
<verification_date>March 2014</verification_date>
<study_first_submitted>September 23, 1999</study_first_submitted>
<study_first_submitted_qc>September 23, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 24, 1999</study_first_posted>
<last_update_submitted>March 5, 2014</last_update_submitted>
<last_update_submitted_qc>March 5, 2014</last_update_submitted_qc>
<last_update_posted type="Estimate">March 6, 2014</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Amblyopia</keyword>
<keyword>patching</keyword>
<keyword>atropine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Amblyopia</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Atropine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000170
org study id: NEI-73
secondary id: 2U10EY011751
secondary id: 5U10EY011751
nct id: NCT00000170
lead sponsor:
collaborator:
has dmc: Yes
- To determine whether the success rate with drug treatment (atropine) of amblyopia due to
strabismus or anisometropia in patients less than 7 years old is equivalent to the
success rate with occlusion (patching) therapy
- To develop more precise estimates of the success rates of amblyopia treatment
- To identify factors that may be associated with successful treatment of amblyopia
- To collect data on the course of treated amblyopia to provide more precise estimates of
treatment effects than are now available
Extended Follow up of Study Patients
- Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15
years in patients diagnosed with amblyopia before age 7 years.
- Secondary: To determine whether the long-term visual acuity outcome at age 10 years and
at age 15 years differs between patients who received patching followed by best clinical
care and patients who received atropine followed by best clinical care
Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often
persists in adulthood. It is reported to be the leading cause of vision loss in one eye in
the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating
that both improved means of detection and treatment are needed.
Most of the available data on the natural history of amblyopia and success rates of its
treatment with either patching or drug therapy are retrospective and uncontrolled. Despite
the common occurrence of amblyopia, there is little quality data on treatment of this
condition. Thus, there is much to be learned about the course of treated amblyopia, to
provide more precise estimates of success rates and to identify factors that may be
associated with successful and unsuccessful treatment.
Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the
sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike
of wearing a patch for visual, skin irritation, and social/psychological reasons. There is
evidence that compliance may be one of, if not, the most important determinant of success of
amblyopia therapy.
An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the
pupils and blurs the image seen by the sound eye, has been known for almost a century. This
method has been widely used for the management of occlusion treatment failures and for
maintenance therapy. However, it has seen little use as a primary treatment for amblyopia.
Clinical experience has found that it has a high acceptability to patients and parents, and
hence high compliance. In addition to its acceptability, pharmacologic therapy has the known
advantage over occlusion of providing a wider visual field with both eyes, which may have
safety and other functional implications. There is also clinical and laboratory evidence
suggesting that drug therapy may maintain and improve the ability to see with both eyes
(binocularity).
Available data suggest that the success rate with drug therapy is as good as, if not better
than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If
this is true, for many children with amblyopia, drug therapy may be the preferred initial
therapy since it appears to be more readily accepted by the children and parents. Despite
data to support the use of drug therapy as a primary therapy for amblyopia, it has gained
only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes
from occlusion therapy and drug therapy is justified in order to determine if new practice
guidelines for treatment of amblyopia are needed.
Regardless of whether the trial determines that one therapeutic approach is better than the
other, the data that are collected will provide valuable information about the course of
amblyopia treatment that is not presently available. The study also is expected to provide
data that will help to determine whether factors such as age, refractive status, cause of
amblyopia, or fixation pattern should be considered in determining which procedure is best
for a given patient.
Extended Follow-up of Study Patients
The extended follow up study consists of annual visits prior to age 10, followed by a visit
at age 10 years and a visit at age 15 years. There is no amblyopia treatment that is required
during the extended follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity in the amblyopic eye
time frame: 6 months
measure: Visual acuity in the amblyopic eye
time frame: 24 months
measure: Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years
time frame: age 10 years and age 15 years
measure: Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
time frame: age 10 years and age 15 years
arm group label: Patching
arm group type: Active Comparator
arm group label: Atropine
arm group type: Active Comparator
description: Atropine
intervention type: Drug
intervention name: Atropine
description: Atropine
arm group label: Atropine
intervention type: Device
intervention name: Eye Patch
description: Patching
arm group label: Patching
criteria:
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
last name: Michael X. Repka, M.D.
role: Study Chair
affiliation: Wilmer Eye Institute
facility:
country: United States
url: http://www.nei.nih.gov/news/pressreleases/031302.asp
description: ATS Press Release March 13, 2002
citation: Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.
PMID: 11879129
citation: Pediatric Eye Disease Investigator Group. The clinical profile of moderate amblyopia in children younger than 7 years. Arch Ophthalmol. 2002 Mar;120(3):281-7.
PMID: 11879130
citation: Cole SR, Beck RW, Moke PS, Celano MP, Drews CD, Repka MX, Holmes JM, Birch EE, Kraker RT, Kip KE; Pediatric Eye Disease Investigator Group. The Amblyopia Treatment Index. J AAPOS. 2001 Aug;5(4):250-4. doi: 10.1067/mpa.2001.117097.
PMID: 11507585
citation: Holmes JM, Beck RW, Repka MX, Leske DA, Kraker RT, Blair RC, Moke PS, Birch EE, Saunders RA, Hertle RW, Quinn GE, Simons KA, Miller JM; Pediatric Eye Disease Investigator Group. The amblyopia treatment study visual acuity testing protocol. Arch Ophthalmol. 2001 Sep;119(9):1345-53. doi: 10.1001/archopht.119.9.1345.
PMID: 11545641
citation: Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age, cause of amblyopia, depth of amblyopia, and other factors. Ophthalmology. 2003 Aug;110(8):1632-7; discussion 1637-8. doi: 10.1016/S0161-6420(03)00500-1.
PMID: 12917184
citation: Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):630-9. doi: 10.1016/s0002-9394(03)00458-6.
PMID: 14516802
citation: Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with patching in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):620-9. doi: 10.1016/s0002-9394(03)00392-1.
PMID: 14516801
citation: Holmes JM, Beck RW, Kraker RT, Cole SR, Repka MX, Birch EE, Felius J, Christiansen SP, Coats DK, Kulp MT; Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.
PMID: 14609923
citation: Repka MX, Wallace DK, Beck RW, Kraker RT, Birch EE, Cotter SA, Donahue S, Everett DF, Hertle RW, Holmes JM, Quinn GE, Scheiman MM, Weakley DR; Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. doi: 10.1001/archopht.123.2.149.
PMID: 15710809
citation: Repka MX, Holmes JM, Melia BM, Beck RW, Gearinger MD, Tamkins SM, Wheeler DT; Pediatric Eye Disease Investigator Group. The effect of amblyopia therapy on ocular alignment. J AAPOS. 2005 Dec;9(6):542-5. doi: 10.1016/j.jaapos.2005.07.009.
PMID: 16414520
citation: Repka MX, Melia M, Eibschitz-Tsimhoni M, London R, Magoon E; Pediatric Eye Disease Investigator Group. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS. 2007 Jun;11(3):300-2. doi: 10.1016/j.jaapos.2006.09.017.
PMID: 17572346
citation: Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Beck RW, Holmes JM, Cotter SA, Birch EE, Astle WF, Chandler DL, Felius J, Arnold RW, Tien DR, Glaser SR. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol. 2008 Aug;126(8):1039-44. doi: 10.1001/archopht.126.8.1039.
PMID: 18695096
citation: Repka MX, Kraker RT, Beck RW, Cotter SA, Holmes JM, Arnold RW, Astle WF, Sala NA, Tien DR; Pediatric Eye Disease Investigator Group. Monocular oral reading performance after amblyopia treatment in children. Am J Ophthalmol. 2008 Dec;146(6):942-7. doi: 10.1016/j.ajo.2008.06.022. Epub 2008 Aug 16.
PMID: 18708179
responsible party type: Sponsor
mesh term: Amblyopia
mesh term: Atropine
|
NCT0000xxxx/NCT00000171.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000171</url>
</required_header>
<id_info>
<org_study_id>IA0006</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000171</nct_id>
</id_info>
<brief_title>Study of Melatonin: Sleep Problems in Alzheimer's Disease</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated
with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of
AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for
caregivers. Alternatives are sorely needed to the currently available sleep medications that
have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone
secreted by the pineal gland. It has soporific effects with oral administration and is well
tolerated. It enhances sleep in normal older people. Melatonin also may help sleep
disturbances associated with AD; however, this remains to be proven.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
In Alzheimer's disease , sleep disruption is one of the most common behavioral problems,
occurring in 45 percent of patients. These nocturnal awakenings and agitation lead to
considerable burden for caregivers and frequently lead families to the decision of nursing
home placement. The proposed study is a randomized, double blind, parallel group, placebo
controlled, clinical trial. Placebo will be compared with two doses of melatonin: a 2.5 mg,
slow- release preparation and a 10 mg immediate release preparation. One hundred and fifty
community-residing AD patients with disrupted sleep will be recruited. Included subjects will
meet NINCDS-ADRDA criteria for probable AD. Prior to study entry, disrupted sleep will be
documented by clinical history and by 1 to 2 weeks of recording using wrist activity
monitors. The treatment period will last 8 weeks. Rest/activity patterns will be recorded by
wrist activity monitors. The primary outcome measure will be the change in nocturnal sleep
time from baseline to the end of the treatment phase.

Other outcomes also will be examined, including the time awake after sleep onset, sleep
latency, sleep efficiency, daytime agitation, and changes in cognition. The relative
effectiveness of high and low dose melatonin will be assessed. Adverse events and side
effects will be compared by treatment. This study should provide the data necessary to
determine whether melatonin is a safe and effective treatment for disrupted sleep associated
with AD.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<condition>Dyssomnias</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Melatonin</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD).
Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks
of recording using wrist activity monitors.

- A diagnosis of probable AD.

- MMSE score 0-26.

- Hachinski Ischemia Scale score less than or equal to 4.

- A 2-week history of two or more sleep disorder behaviors, occurring at least once
weekly, as reported by the caregiver on the Sleep Disorder Inventory.

- CT or MRI since the onset of memory problems showing no more than one lacunar infarct
in a non-strategic area and no clinical events suggestive of stroke or other
intracranial disease since the CT or MRI.

- Physically acceptable for study as confirmed by medical history and exam, clinical
laboratory results, and EKG.

- Actigraph evidence of a mean nocturnal sleep time of less than 7 hours per night (at
least 5 nights of complete actigraph data must be collected over a single week.

- Stable home situation with no planned move during the 13-week investigational period.

- Residing with responsible spouse, family member, or professional caregiver who is
present during the night and will agree to assume the role of the principal caregiver
for the 13-week protocol, including arranging transport for the patient to and from
the investigators' clinic, answering questions regarding the patient's condition, and
assuming responsibility for medication and actigraph procedures.

- Ability to ingest oral medication and participate in all scheduled evaluations.

- Six grades of education or work history sufficient to exclude mental retardation.

- 55 years of age or older.

- Hamilton Depression Rating Scale score of 15 or less.

- Stable medication (dose and type) for non-excluded concurrent medical conditions for 4
weeks prior to the screening visit.

Exclusion Criteria:

- Sleep disturbance is acute (within the last 2 weeks).

- Sleep disturbance is associated with an acute illness with delirium.

- Clinically significant movement disorder that would interfere with the actigraph
readings.

- Not having a mobile upper extremity to which to attach an actigraph.

- Severe agitation.

- Pain syndrome affecting sleep.

- Unstable medical condition.

- Use of investigational or unapproved medications within 4 weeks of the screening
visit.

- Patient unwilling to maintain caffeine abstinence after 2:00 pm for the duration of
the protocol.

- Patient unwilling to comply with the maximum limit of two alcoholic drinks per day,
and only one alcoholic drink after 6:00 pm for the duration of the protocol.

- Use of melatonin within 2 weeks of screening visit.

- Clinically significant abnormal laboratory findings that have not been approved by the
Project Director.

- Residing in a facility without a consistent caregiver present during the night who can
function as the primary informant.

- Caregiver deemed too unreliable to supervise the wearing of the actigraph, to maintain
the sleep diary, or to bring the patient to the scheduled visits.

- Autoimmune disease, such as rheumatoid arthritis and polymyalgia rheumatica.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Cliff Singer, M.D.</last_name>
<role>Study Director</role>
<affiliation>Oregon Health and Science University</affiliation>
</overall_official>
<location>
<facility>
<name>University of Arizona</name>
<address>
<city>Tucson</city>
<state>Arizona</state>
<zip>85724-5023</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California Irvine Institute for Brain Aging and Dementia</name>
<address>
<city>Irvine</city>
<state>California</state>
<zip>92697-4285</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>La Jolla</city>
<state>California</state>
<zip>92037</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033-1039</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, Los Angeles</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095-1769</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Yale University, Alzheimer's Disease ResearchUnit</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520-8037</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai (Miami)</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33140</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30329</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Augusta VA Medical Center</name>
<address>
<city>Augusta</city>
<state>Georgia</state>
<zip>30904</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southern Illinois University</name>
<address>
<city>Springfield</city>
<state>Illinois</state>
<zip>62702</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kansas Medical Center</name>
<address>
<city>Kansas City</city>
<state>Kansas</state>
<zip>66160</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kentucky</name>
<address>
<city>Lexington</city>
<state>Kentucky</state>
<zip>40536-0230</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic at Rochester</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>11032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Rochester Medical Center</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Hospitals of Cleveland</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44120</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oregon Health Sciences University</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201-3098</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104-4283</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pittsburgh</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15213</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Brown University</name>
<address>
<city>Pawtucket</city>
<state>Rhode Island</state>
<zip>02860</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37212-8646</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75235</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Washington</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.alzheimers.org</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).</description>
</link>
<reference>
<citation>Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.</citation>
<PMID>14655926</PMID>
</reference>
<verification_date>March 2005</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>Sleep disorders</keyword>
<keyword>Melatonin</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
<mesh_term>Dyssomnias</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Melatonin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000171
org study id: IA0006
secondary id: 3U01AG010483-08S2
nct id: NCT00000171
lead sponsor:
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated
with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of
AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for
caregivers. Alternatives are sorely needed to the currently available sleep medications that
have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone
secreted by the pineal gland. It has soporific effects with oral administration and is well
tolerated. It enhances sleep in normal older people. Melatonin also may help sleep
disturbances associated with AD; however, this remains to be proven.
In Alzheimer's disease , sleep disruption is one of the most common behavioral problems,
occurring in 45 percent of patients. These nocturnal awakenings and agitation lead to
considerable burden for caregivers and frequently lead families to the decision of nursing
home placement. The proposed study is a randomized, double blind, parallel group, placebo
controlled, clinical trial. Placebo will be compared with two doses of melatonin: a 2.5 mg,
slow- release preparation and a 10 mg immediate release preparation. One hundred and fifty
community-residing AD patients with disrupted sleep will be recruited. Included subjects will
meet NINCDS-ADRDA criteria for probable AD. Prior to study entry, disrupted sleep will be
documented by clinical history and by 1 to 2 weeks of recording using wrist activity
monitors. The treatment period will last 8 weeks. Rest/activity patterns will be recorded by
wrist activity monitors. The primary outcome measure will be the change in nocturnal sleep
time from baseline to the end of the treatment phase.
Other outcomes also will be examined, including the time awake after sleep onset, sleep
latency, sleep efficiency, daytime agitation, and changes in cognition. The relative
effectiveness of high and low dose melatonin will be assessed. Adverse events and side
effects will be compared by treatment. This study should provide the data necessary to
determine whether melatonin is a safe and effective treatment for disrupted sleep associated
with AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Melatonin
criteria:
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Cliff Singer, M.D.
role: Study Director
affiliation: Oregon Health and Science University
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.alzheimers.org
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).
citation: Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
PMID: 14655926
mesh term: Alzheimer Disease
mesh term: Dyssomnias
mesh term: Melatonin
|
NCT0000xxxx/NCT00000172.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000172</url>
</required_header>
<id_info>
<org_study_id>IA0009</org_study_id>
<nct_id>NCT00000172</nct_id>
</id_info>
<brief_title>Evaluation of Galantamine in the Treatment of Alzheimer's Disease</brief_title>
<official_title>Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen</official_title>
<sponsors>
<lead_sponsor>
<agency>Janssen, LP</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
Galantamine is an experimental drug being evaluated in the United States for the treatment of
Alzheimer's disease. Results from previous clinical trials suggest that galantamine may
improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for
Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function
communicate using a chemical called acetylcholine. Research has shown that deterioration of
cells that produce acetylcholine in the brain affects thought processes. Galantamine is
thought to work in two ways to increase the amount of acetylcholine available in the brain.
It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic
receptors in the brain to release more acetylcholine.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up
to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day
galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind
treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and
CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be
evaluated based on adverse event reports, laboratory values, ECG, and vital signs with
particular focus on the adverse event rates in the slower titration schedule for 24 mg/day.
Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo.
Information on the dose response relationship of galantamine will be evaluated.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Galantamine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Probable Alzheimer's disease

- Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18

- Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least
18

- Opportunity for Activities of Daily Living

- Caregiver

- Subjects who live with or have regular daily visits from a responsible caregiver
(visit frequency: preferably daily but at least 5 days/week). This includes a friend
or relative or paid personnel. The caregiver should be capable of assisting with the
subject's medication, prepared to attend with the subject for assessments, and willing
to provide information about the subject.

Exclusion Criteria:

- Conditions that could confound diagnosis

- Neurodegenerative disorders

- Acute cerebral trauma

- Psychiatric disease

- More than one infarct on CT/MRI scans

- History of alcohol or drug abuse

- Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions
(including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV
block.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>0 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<location>
<facility>
<name>University of Alabama, Birmingham</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294-0017</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>James L. Frey, M.D., Ltd.</name>
<address>
<city>Scottsdale</city>
<state>Arizona</state>
<zip>85258</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>East Bay Neurology</name>
<address>
<city>Berkeley</city>
<state>California</state>
<zip>94705</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033-1039</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>N. County Neurology Assoc.</name>
<address>
<city>Oceanside</city>
<state>California</state>
<zip>92056</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California Irvine Medical Center</name>
<address>
<city>Orange</city>
<state>California</state>
<zip>92868</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pacific Research Network (PRN)</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92103</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Research Institute</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>INC</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92122</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Denver Center for Medical Research</name>
<address>
<city>Denver</city>
<state>Colorado</state>
<zip>80212</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Geriatric and Adult Psychiatry</name>
<address>
<city>Hamden</city>
<state>Connecticut</state>
<zip>06518</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Yale University, School of Medicine</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Ocala Neurodiagnostic Center</name>
<address>
<city>Ocala</city>
<state>Florida</state>
<zip>34471</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Psychiatric Institute of Florida</name>
<address>
<city>Orlando</city>
<state>Florida</state>
<zip>32806</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neurological Research Institute of Sarasota, PA</name>
<address>
<city>Sarasota</city>
<state>Florida</state>
<zip>34239</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Suncoast Neuroscience Associates, Inc.</name>
<address>
<city>St. Petersburg</city>
<state>Florida</state>
<zip>33701</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Premiere Research Institute</name>
<address>
<city>West Palm Beach</city>
<state>Florida</state>
<zip>33407</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Chicago Center for Clinical Research</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>606104234</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>OSF Center for Senior Health</name>
<address>
<city>Peoria</city>
<state>Illinois</state>
<zip>616033089</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana Alzheimer's University Clinic</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202-5111</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>The Johns Hopkins Hospital</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21287</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Brigham Behavioral Neurology Group</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Boston Clinical Research Center</name>
<address>
<city>Wellesley Hills</city>
<state>Massachusetts</state>
<zip>02481</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Massachusetts Worcester</name>
<address>
<city>Worcester</city>
<state>Massachusetts</state>
<zip>01655</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oakwood Hospital and Medical Center</name>
<address>
<city>Dearborn</city>
<state>Michigan</state>
<zip>48124</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Michigan Medical P.C.</name>
<address>
<city>Grand Rapids</city>
<state>Michigan</state>
<zip>49503</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Regions Hospital</name>
<address>
<city>St. Paul</city>
<state>Minnesota</state>
<zip>55101</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Louis University School of Medicine</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Nebraska</name>
<address>
<city>Omaha</city>
<state>Nebraska</state>
<zip>681985575</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Medicine and Dentistry of New Jersey</name>
<address>
<city>Piscataway</city>
<state>New Jersey</state>
<zip>088551392</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neurology Group of Bergen County</name>
<address>
<city>Ridgewood</city>
<state>New Jersey</state>
<zip>07450</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Overlook Hospital</name>
<address>
<city>Summit</city>
<state>New Jersey</state>
<zip>07901</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medwise Center</name>
<address>
<city>West Long Branch</city>
<state>New Jersey</state>
<zip>07764</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neurological Associates of Albany, PC</name>
<address>
<city>Albany</city>
<state>New York</state>
<zip>12208</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>East End Neuropsychiatric Associates</name>
<address>
<city>Centereach</city>
<state>New York</state>
<zip>11720</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. John's Episcopal Hospital</name>
<address>
<city>Far Rockaway</city>
<state>New York</state>
<zip>11691</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>NYU Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Rochester</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY Stony Brook</name>
<address>
<city>Stony Brook</city>
<state>New York</state>
<zip>11794-8121</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Ohio State University</name>
<address>
<city>Columbus</city>
<state>Ohio</state>
<zip>43210</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinical Pharmaceutical Trials</name>
<address>
<city>Tulsa</city>
<state>Oklahoma</state>
<zip>741025428</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oregon Health Sciences University</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201-3098</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pacific NW Clinical Research Center</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Institute for Advanced Clinical Research</name>
<address>
<city>Elkins Park</city>
<state>Pennsylvania</state>
<zip>19027</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neuroscience Center of Westmoreland Neurology</name>
<address>
<city>Greensburg</city>
<state>Pennsylvania</state>
<zip>15601</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Brown University</name>
<address>
<city>Pawtucket</city>
<state>Rhode Island</state>
<zip>02906</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Alzheimer's Research and Clinical Programs</name>
<address>
<city>North Charleston</city>
<state>South Carolina</state>
<zip>294066076</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>752359070</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southwestern Vermont Medical Center</name>
<address>
<city>Bennington</city>
<state>Vermont</state>
<zip>05201</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Memory Disorder Center of Vermont</name>
<address>
<city>Colchester</city>
<state>Vermont</state>
<zip>05446</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Virginia Neuroscience Center</name>
<address>
<city>Alexandria</city>
<state>Virginia</state>
<zip>22304</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Prince William Neuroscience Center</name>
<address>
<city>Manassas</city>
<state>Virginia</state>
<zip>20010</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Seattle Clinical Research Center</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>VAPS Health Care System</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. doi: 10.1159/000051228.</citation>
<PMID>10971048</PMID>
</reference>
<verification_date>November 2002</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>Cholinergic agents</keyword>
<keyword>Cholinergic agonists</keyword>
<keyword>Cholinesterase inhibitors</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Galantamine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000172
org study id: IA0009
nct id: NCT00000172
lead sponsor:
Galantamine is an experimental drug being evaluated in the United States for the treatment of
Alzheimer's disease. Results from previous clinical trials suggest that galantamine may
improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for
Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function
communicate using a chemical called acetylcholine. Research has shown that deterioration of
cells that produce acetylcholine in the brain affects thought processes. Galantamine is
thought to work in two ways to increase the amount of acetylcholine available in the brain.
It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic
receptors in the brain to release more acetylcholine.
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up
to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day
galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind
treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and
CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be
evaluated based on adverse event reports, laboratory values, ECG, and vital signs with
particular focus on the adverse event rates in the slower titration schedule for 24 mg/day.
Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo.
Information on the dose response relationship of galantamine will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Galantamine
criteria:
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
facility:
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facility:
facility:
facility:
facility:
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facility:
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country: United States
citation: Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. doi: 10.1159/000051228.
PMID: 10971048
mesh term: Alzheimer Disease
mesh term: Galantamine
|
NCT0000xxxx/NCT00000173.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000173</url>
</required_header>
<id_info>
<org_study_id>IA0011</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000173</nct_id>
</id_info>
<brief_title>Memory Impairment Study (Mild Cognitive Impairment Study)</brief_title>
<official_title>A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin E and Donepezil HCL (Aricept) to Delay Clinical Progression From Mild Cognitive Impairment (MCI) to Alzheimer's Disease (AD)</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Alzheimer's Disease Cooperative Study (ADCS)</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
The National Institute on Aging (NIA) is launching a nationwide treatment study targeting
individuals with mild cognitive impairment (MCI), a condition characterized by a memory
deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from
both dementia and normal age-related changes in memory. Accurate and early evaluation and
treatment of MCI individuals might prevent further cognitive decline, including development
of Alzheimer's disease (AD).

The Memory Impairment Study is the first such AD prevention clinical trial carried out by
NIH, and will be conducted at 65-80 medical research institutions located in the United
States and Canada. This study will test the usefulness of two drugs to slow or stop the
conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an
investigational agent approved by the Food and Drug Administration for another use. Vitamin E
(alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study
to delay important dementia milestones, such as patients' institutionalization or progression
to severe dementia, by about seven months.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
This clinical trial will be a multicenter, randomized, double-blind, placebo- controlled,
parallel-group study of vitamin E and donepezil in 720 subjects with mild cognitive
impairment (MCI). Subjects will be randomized to one of three treatment groups (240 subjects
per treatment group): 1) Placebo vitamin E and placebo donepezil plus a multivitamin daily.
2) Vitamin E (2,000 I) and placebo donepezil plus a multivitamin daily.3) Donepezil (10 mg)
and placebo vitamin E plus a multivitamin daily.

The study will be conducted over three years, with clinical evaluations every 3 months for
the first 6 months and then every 6 months. Subjects randomized to donepezil will start a
dose of 5 mg daily. Donepezil will be increased to 10 mg after six weeks. Subjects randomized
to vitamin E will start at 1,000 I daily. The dose of Vitamin E will be increased to 2,000 I
after six weeks. There will be a 12-month recruitment period. The primary endpoint will be
time to development of Probable or Possible AD according to NINCDS-ADRDA criteria. Upon
determination of a clinical diagnosis of AD, documentation will be sent to the ADCS
Coordinating Center and forwarded to the Central Review Committee for verification. Upon
verification, of conversion to diagnosis of AD, subjects will stop taking the donepezil study
medication or its corresponding placebo, without breaking the blind, and will be offered open
label donepezil at a scheduled visit one month after the prior diagnostic visit. Donepezil
will be offered to subjects who convert to AD until the subject completes three years from
the baseline visit. Based on an estimated incidence of AD of 15% per year, the study has 85%
power to detect a 33% or greater reduction in conversion to AD over 3 years. Secondary
outcome measures will include change on the Alzheimer's Disease Assessment Scale (ADAS-COG),
the Neuropsychological Battery, the Mini-Mental State Exam (MMSE), Clinical Dementia Rating
Scale (CDR), the Global Deterioration Scale (GDS), ADCS- Activities of Daily Living Inventory
(ADCS-ADL), a Pharmacoeconomics scale, and a Quality of Life scale. Compliance will be
monitored through the measurement of alpha-tocopherol levels and pill counts at each visit.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>March 1999</start_date>
<completion_date type="Actual">January 2004</completion_date>
<primary_completion_date type="Actual">January 2004</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Donepezil</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Vitamin E</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Memory complaints and memory difficulties which are verified by an informant.

- Abnormal memory function documented by scoring below the education adjusted cutoff on
the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory
Scale - Revised (the maximum score is 25): a) less than or equal to 8 for 16 or more
years of education, b) less than or equal to 4 for 8-15 years of education, c) less
than or equal to 2 for 0-7 years of education.

- Mini-Mental Exam score between 24 and 30 (inclusive) (Exceptions may be made for
subjects with less than 8 years of education at the discretion of the project
director.).

- Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5.

- General cognition and functional performance sufficiently preserved such that a
diagnosis of Alzheimer's disease cannot be made by the site physician at the time of
the screening visit.

- No significant cerebrovascular disease: Modified Hachinski score of less than or equal
to 4.

- Age between 55 and 90 (inclusive).

- Permitted medications stable for at least 1 month prior to screening. In particular:
a) Subjects may take stable doses of antidepressants lacking significant
anticholinergic side effects (if they are not currently depressed and do not have a
history of major depression within the past 2 years). b) Estrogen replacement therapy
is permissible. c) Ginkgo biloba is permissible, but discouraged.

- Hamilton Depression rating scale score of less than or equal to 12 on the 17-item
scale.

- Informant is available who has frequent contact with the subject (e.g. an average of
10 hours per week or more), agrees to monitor administration of study drug, observe
for adverse events, and accompany the subject to all clinic visits for the duration of
the protocol.

- CT or MRI scans within 12 months prior to screening without evidence of infection,
infarction, or other focal lesions and without clinical symptoms suggestive of
intervening neurological disease. A lacune in a non-critical brain area which is not
believed to contribute to the subject's cognitive impairment is permissible.

- Adequate visual and auditory acuity to allow neuropsychological testing.

- Good general health with no additional diseases expected to interfere with the study.

- Normal B12, RPR, and Thyroid Function Tests or without any clinically significant
abnormalities that would be expected to interfere with the study.

- ECG without clinically significant abnormalities that would be expected to interfere
with the study.

- Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be
two years post-menopausal or surgically sterile).

- Agreement not to take other vitamin supplements (including Vitamin E), multivitamins,
other than those provided by the study.

Exclusion Criteria:

- Any significant neurologic disease other than suspected incipient Alzheimer's disease,
such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal
pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,
subdural hematoma, multiple sclerosis, or history of significant head trauma followed
by persistent neurologic defaults or known structural brain abnormalities.

- Major depression or another major psychiatric disorder as described in DSM IV within
the past 2 years.

- Psychotic features, agitation or behavioral problems within the last 3 months which
could lead to difficulty complying with the protocol.

- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV
criteria).

- History of schizophrenia (DSM IV criteria).

- Any significant systemic illness or unstable medical condition which could lead to
difficulty complying with the protocol including: a) History of systemic cancer within
the last 5 years (non-metastatic skin cancers are acceptable). b) History of
myocardial infarction within the past year or unstable or severe cardiovascular
disease including angina or CHF with symptoms at rest. c) Clinically significant
obstructive pulmonary disease or asthma. d) Clinically significant and unstable
gastrointestinal disorder such as ulcer disease or a history of active or occult
gastrointestinal bleeding within two years. e) Clinically significant laboratory test
abnormalities on the battery of screening tests (hematology, prothrombin time,
chemistry, urinalysis, ECG). f) Insulin-requiring diabetes or uncontrolled diabetes
mellitus. g) Uncontrolled hypertension (systolic BP greater than 170 or diastolic
greater than 100). h) History of clinically significant liver disease, coagulopathy,
or vitamin K deficiency within the past 2 years.

- Medications a) Use of centrally active beta-blockers, narcotics, methyldopa and
clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications
(e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months
prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior
to screening. d) Use of long-acting benzodiazepines or barbituates within 4 weeks
prior to screening. e) Use of short-acting anxiolytics or sedative hypnotics more
frequently than 2 times per week within 4 weeks prior to screening (note: sedative
agents should not be used within 72 hours of screening).

f) Initiation or change in dose of an antidepressant lacking significant cholinergic
side effects within the 4 weeks prior to screening (use of stable doses of
antidepressants for at least 4 weeks prior to screening is acceptable). g) Use of
systemic corticosteroids within 3 months prior to screening. h) Medications with
significant cholinergic or anticholinergic side effects (e.g. pyridostigmine,
tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to
screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine)
within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior
to screening.

- Vitamin Supplements a) Use of vitamin supplements other than standard multivitamin
included as part of the treatment intervention used in this protocol within 2 weeks
prior to screening.

- Any prior use of any FDA approved medications for the treatment of Alzheimer's disease
(e.g. tacrine, donepezil, or other newly approved medications).

- Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer,
prior to screening.

- Subjects who, in the investigator's opinion, will not comply with study procedures.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Leon Thal, MD</last_name>
<role>Principal Investigator</role>
<affiliation>Alzheimer's Disease Cooperative Study</affiliation>
</overall_official>
<location>
<facility>
<name>Barrow Neurological Group</name>
<address>
<city>Phoenix</city>
<state>Arizona</state>
<zip>85013</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Arizona</name>
<address>
<city>Tucson</city>
<state>Arizona</state>
<zip>857245023</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>UC Irvine Institute for Brain Aging and Dementia</name>
<address>
<city>Irvine</city>
<state>California</state>
<zip>92697-4285</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, Los Angeles</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095-1769</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>East Bay Institute</name>
<address>
<city>Martinez</city>
<state>California</state>
<zip>94553</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sutter Institute for Medical Research</name>
<address>
<city>Sacramento</city>
<state>California</state>
<zip>95816</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Affiliated Research Instiute</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92018</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093-0949</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Francisco</name>
<address>
<city>San Francisco</city>
<state>California</state>
<zip>94115</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Yale University</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06520</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baumel-Eisner Neuromedical Institute, Boca Raton</name>
<address>
<city>Boca Raton</city>
<state>Florida</state>
<zip>33486</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baumel-Eisner Neuromedical Institute, Ft. Lauderdale</name>
<address>
<city>Ft. Lauderdale</city>
<state>Florida</state>
<zip>33321</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wein Center</name>
<address>
<city>Miami Beach</city>
<state>Florida</state>
<zip>33140</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baumel-Eisner Neuromedical Institute, MiamiBeach</name>
<address>
<city>Miami Beach</city>
<state>Florida</state>
<zip>33154</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Miami</name>
<address>
<city>Port Charlotte</city>
<state>Florida</state>
<zip>33952</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33612</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Premiere Research Institute</name>
<address>
<city>West Palm Beach</city>
<state>Florida</state>
<zip>33407</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30329</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Augusta VA Medical Center</name>
<address>
<city>Augusta</city>
<state>Georgia</state>
<zip>30904</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Northwestern University</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60611</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Rush Presbyterian St. Luke's Medical Center</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60612</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southern Illinois University</name>
<address>
<city>Springfield</city>
<state>Illinois</state>
<zip>62702</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202-5111</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kansas Medical Center</name>
<address>
<city>Kansas City</city>
<state>Kansas</state>
<zip>66160</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kentucky</name>
<address>
<city>Lexington</city>
<state>Kentucky</state>
<zip>40536-0230</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Massachusetts General Hospital</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>55901-0144</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Nevada</name>
<address>
<city>Las Vegas</city>
<state>Nevada</state>
<zip>89102</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Dartmouth Hitchcock Medical Center</name>
<address>
<city>Lebanon</city>
<state>New Hampshire</state>
<zip>03756</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Memory Disorders Institute</name>
<address>
<city>Lakehurst</city>
<state>New Jersey</state>
<zip>08733</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Princeton Biomedical Research, PA</name>
<address>
<city>Princeton</city>
<state>New Jersey</state>
<zip>08540</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>ClinSearch, Inc.</name>
<address>
<city>Summit</city>
<state>New Jersey</state>
<zip>07901</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Princeton Biomedical - Toms River</name>
<address>
<city>Toms River</city>
<state>New Jersey</state>
<zip>08755</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Alzheimer's Research Corp.</name>
<address>
<city>West Long Branch</city>
<state>New Jersey</state>
<zip>07764</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Univ. of New Mexico</name>
<address>
<city>Albuquerque</city>
<state>New Mexico</state>
<zip>89108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Maimonides Medical Center</name>
<address>
<city>Brooklyn</city>
<state>New York</state>
<zip>11219</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>NYU Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>11032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Nathan S. Kline Institute for Psychiatric Research</name>
<address>
<city>Orangeburg</city>
<state>New York</state>
<zip>10962</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Rochester</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>SUNY Stony Brook</name>
<address>
<city>Stony Brook</city>
<state>New York</state>
<zip>11794-8121</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Burke Medical Research Institute</name>
<address>
<city>White Plains</city>
<state>New York</state>
<zip>10605</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University Medical Center</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<zip>27705</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Hospitals of Cleveland</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44120-1013</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oregon Health Sciences University</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201-3098</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>MCP Hahnemann</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19129</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pittsburgh</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15213</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Brown University</name>
<address>
<city>Pawtucket</city>
<state>Rhode Island</state>
<zip>02860</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medical University of South Carolina</name>
<address>
<city>North Charleston</city>
<state>South Carolina</state>
<zip>29406</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37212-8646</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southwestern Vermont Medical Center</name>
<address>
<city>Bennington</city>
<state>Vermont</state>
<zip>05201</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinical Neuroscience Research Unit</name>
<address>
<city>Burlington</city>
<state>Vermont</state>
<zip>05401</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Washington</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Marshfield Clinic</name>
<address>
<city>Marshfield</city>
<state>Wisconsin</state>
<zip>54449</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Calgary</name>
<address>
<city>Calgary</city>
<state>Alberta</state>
<zip>T2N 4N1</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of British Columbia</name>
<address>
<city>Vancouver</city>
<state>British Columbia</state>
<zip>V6T 2B5</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Fredericton Medical Clinic</name>
<address>
<city>Fredericton</city>
<state>New Brunswick</state>
<zip>E3B 6H5</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Geriatric Medicine Research Group</name>
<address>
<city>Halifax</city>
<state>Nova Scotia</state>
<zip>B3H 2E1</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Joseph's Health Center</name>
<address>
<city>London</city>
<state>Ontario</state>
<zip>N6A 4V2</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Elizabeth Bruyere Centre</name>
<address>
<city>Ottawa</city>
<state>Ontario</state>
<zip>K1N 5C8</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Sunnybrook Health Science Center</name>
<address>
<city>Toronto</city>
<state>Ontario</state>
<zip>M4N 3M5</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Jewish General Hospital Memory Clinic</name>
<address>
<city>Montreal</city>
<state>Quebec</state>
<zip>H3T 1E2</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location>
<facility>
<name>McGill Centre for Studies in Aging</name>
<address>
<city>Verdun</city>
<state>Quebec</state>
<zip>H4H 1R3</zip>
<country>Canada</country>
</address>
</facility>
</location>
<location_countries>
<country>Canada</country>
<country>United States</country>
</location_countries>
<link>
<url>http://adcs.ucsd.edu</url>
<description>More information about the study from the Alzheimer's Disease Cooperative Study site at the University of California at San Diego.</description>
</link>
<link>
<url>http://www.alzheimers.org</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging.</description>
</link>
<reference>
<citation>Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998 Jan;50(1):136-45. doi: 10.1212/wnl.50.1.136.</citation>
<PMID>9443470</PMID>
</reference>
<reference>
<citation>Petersen RC, Smith GE, Waring SC, Ivnik RJ, Kokmen E, Tangelos EG. Aging, memory, and mild cognitive impairment. Int Psychogeriatr. 1997;9 Suppl 1:65-9. doi: 10.1017/s1041610297004717.</citation>
<PMID>9447429</PMID>
</reference>
<reference>
<citation>Rubin EH, Morris JC, Grant EA, Vendegna T. Very mild senile dementia of the Alzheimer type. I. Clinical assessment. Arch Neurol. 1989 Apr;46(4):379-82. doi: 10.1001/archneur.1989.00520400033016.</citation>
<PMID>2650663</PMID>
</reference>
<results_reference>
<citation>Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.</citation>
<PMID>14732621</PMID>
</results_reference>
<verification_date>June 2009</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>December 10, 2009</last_update_submitted>
<last_update_submitted_qc>December 10, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">December 11, 2009</last_update_posted>
<keyword>Mild cognitive impairment</keyword>
<keyword>Alzheimer's disease</keyword>
<keyword>Memory</keyword>
<keyword>Donepezil</keyword>
<keyword>Vitamin E</keyword>
<keyword>Antioxidants</keyword>
<keyword>Cholinergic agents</keyword>
<keyword>Cholinesterase inhibitors</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
<mesh_term>Cognitive Dysfunction</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Vitamin E</mesh_term>
<mesh_term>Donepezil</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000173
org study id: IA0011
secondary id: 3U01AG010483-08S2
nct id: NCT00000173
lead sponsor:
collaborator:
The National Institute on Aging (NIA) is launching a nationwide treatment study targeting
individuals with mild cognitive impairment (MCI), a condition characterized by a memory
deficit, but not dementia. An NIA-funded study recently confirmed that MCI is different from
both dementia and normal age-related changes in memory. Accurate and early evaluation and
treatment of MCI individuals might prevent further cognitive decline, including development
of Alzheimer's disease (AD).
The Memory Impairment Study is the first such AD prevention clinical trial carried out by
NIH, and will be conducted at 65-80 medical research institutions located in the United
States and Canada. This study will test the usefulness of two drugs to slow or stop the
conversion from MCI to AD. The trial will evaluate placebo, vitamin E, and donepezil, an
investigational agent approved by the Food and Drug Administration for another use. Vitamin E
(alpha-tocopherol) is thought to have antioxidant properties, and was shown in a 1997 study
to delay important dementia milestones, such as patients' institutionalization or progression
to severe dementia, by about seven months.
This clinical trial will be a multicenter, randomized, double-blind, placebo- controlled,
parallel-group study of vitamin E and donepezil in 720 subjects with mild cognitive
impairment (MCI). Subjects will be randomized to one of three treatment groups (240 subjects
per treatment group): 1) Placebo vitamin E and placebo donepezil plus a multivitamin daily.
2) Vitamin E (2,000 I) and placebo donepezil plus a multivitamin daily.3) Donepezil (10 mg)
and placebo vitamin E plus a multivitamin daily.
The study will be conducted over three years, with clinical evaluations every 3 months for
the first 6 months and then every 6 months. Subjects randomized to donepezil will start a
dose of 5 mg daily. Donepezil will be increased to 10 mg after six weeks. Subjects randomized
to vitamin E will start at 1,000 I daily. The dose of Vitamin E will be increased to 2,000 I
after six weeks. There will be a 12-month recruitment period. The primary endpoint will be
time to development of Probable or Possible AD according to NINCDS-ADRDA criteria. Upon
determination of a clinical diagnosis of AD, documentation will be sent to the ADCS
Coordinating Center and forwarded to the Central Review Committee for verification. Upon
verification, of conversion to diagnosis of AD, subjects will stop taking the donepezil study
medication or its corresponding placebo, without breaking the blind, and will be offered open
label donepezil at a scheduled visit one month after the prior diagnostic visit. Donepezil
will be offered to subjects who convert to AD until the subject completes three years from
the baseline visit. Based on an estimated incidence of AD of 15% per year, the study has 85%
power to detect a 33% or greater reduction in conversion to AD over 3 years. Secondary
outcome measures will include change on the Alzheimer's Disease Assessment Scale (ADAS-COG),
the Neuropsychological Battery, the Mini-Mental State Exam (MMSE), Clinical Dementia Rating
Scale (CDR), the Global Deterioration Scale (GDS), ADCS- Activities of Daily Living Inventory
(ADCS-ADL), a Pharmacoeconomics scale, and a Quality of Life scale. Compliance will be
monitored through the measurement of alpha-tocopherol levels and pill counts at each visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Donepezil
intervention type: Drug
intervention name: Vitamin E
criteria:
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Leon Thal, MD
role: Principal Investigator
affiliation: Alzheimer's Disease Cooperative Study
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: Canada
country: United States
url: http://adcs.ucsd.edu
description: More information about the study from the Alzheimer's Disease Cooperative Study site at the University of California at San Diego.
url: http://www.alzheimers.org
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging.
citation: Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998 Jan;50(1):136-45. doi: 10.1212/wnl.50.1.136.
PMID: 9443470
citation: Petersen RC, Smith GE, Waring SC, Ivnik RJ, Kokmen E, Tangelos EG. Aging, memory, and mild cognitive impairment. Int Psychogeriatr. 1997;9 Suppl 1:65-9. doi: 10.1017/s1041610297004717.
PMID: 9447429
citation: Rubin EH, Morris JC, Grant EA, Vendegna T. Very mild senile dementia of the Alzheimer type. I. Clinical assessment. Arch Neurol. 1989 Apr;46(4):379-82. doi: 10.1001/archneur.1989.00520400033016.
PMID: 2650663
citation: Grundman M, Petersen RC, Ferris SH, Thomas RG, Aisen PS, Bennett DA, Foster NL, Jack CR Jr, Galasko DR, Doody R, Kaye J, Sano M, Mohs R, Gauthier S, Kim HT, Jin S, Schultz AN, Schafer K, Mulnard R, van Dyck CH, Mintzer J, Zamrini EY, Cahn-Weiner D, Thal LJ; Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004 Jan;61(1):59-66. doi: 10.1001/archneur.61.1.59.
PMID: 14732621
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
mesh term: Vitamin E
mesh term: Donepezil
|
NCT0000xxxx/NCT00000174.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000174</url>
</required_header>
<id_info>
<org_study_id>IA0012</org_study_id>
<nct_id>NCT00000174</nct_id>
</id_info>
<brief_title>Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)</brief_title>
<sponsors>
<lead_sponsor>
<agency>Novartis</agency>
<agency_class>Industry</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,
36-month study comparing the length of time of progression from mild cognitive impairment
(MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.
placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a
treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40
countries for Alzheimer's disease to date, including all 15 member states of the European
Union, New Zealand, Argentina, Brazil and Mexico.

Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.
Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)
for the majority of the study. At every regular visit scheduled every three months, patients
will be given basic efficacy and safety assessments. These assessments will include
evaluation of adverse events, vital signs, activities of daily living, and clinical staging
scales to determine if the subject may have converted to dementia.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<condition>Cognition Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Rivastigmine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to
participate, with approval of the designated study medical monitor.

- Are male or female without child-bearing potential (i.e., surgically sterilized [via
bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year
postmenopausal, or using adequate birth control).

- Are cooperative, able to ingest oral medication, and willing to complete all aspects
of the study.

- Will provide written informed consent prior to their participation in the study.

- Show evidence of mild cognitive impairment (MCI) by meeting all of the following
criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item
HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1.

- Have a friend or family member who is willing to participate in the study as an
informant. The informant must see the subject at least once a week for several hours
and be available to accompany the subject to the screening and baseline visits, and at
a minimum, be accessible by telephone for other scheduled visits.

Exclusion Criteria:

- Advanced, severe, and unstable disease of any type that may interfere with primary and
secondary variable evaluations including any medical condition that could be expected
to progress, recur, or change to such an extent that it may bias the assessment of the
clinical or mental status of the subject to a significant degree or put the subject at
special risk.

- Cognitive impairment sufficient to warrant a diagnosis of dementia.

- Met the DSM-IV and NINCDS-ADRDA criteria for AD.

- A clinical diagnosis of AD.

- A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible
after appropriate treatment of the depressive episode. A minimum of four weeks washout
of antidepressant medication should occur prior to screening. Subjects with a prior
history of depression (but not currently depressed) are allowed in the study.

- Fewer than four years of formal education.

- A documented history of transient ischemic attacks.

- Baseline MRI findings or CT-scan findings within a year of screening that are
consistent with a process other than AD, e.g., stroke, tumor, brain trauma or
hydrocephalus, that may contribute to the subject's MCI. Lacunae infarcts present in
areas affecting cognition (entorhinal cortex, hippocampus, medial temporal lobe) will
also exclude the subject from the study.

- A score of greater than 4 on the Modified Hachinski Ischemic Scale.

- A current diagnosis of any primary neurodegenerative disorder, e.g., Parkinson's
disease.

- A current diagnosis of uncontrolled seizure disorder.

- A current diagnosis of active peptic ulceration.

- A current diagnosis of severe and unstable cardiovascular disease.

- A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block,
second or third degree atrio-ventricular block).

- A current diagnosis of acute, severe, or unstable asthmatic conditions.

- A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar
to Exelon or to other cholinergic compounds (e.g., pilocarpine, bethanechol, tacrine,
velnacrine, donepezil, metrifonate, or physostigmine). Subjects who have experienced
elevations in liver function test parameters on other cholinesterase inhibitors are
still eligible.

- Taken any of the following substances: An investigational drug during the past four
weeks; Metrifonate during the past three months; a drug or treatment known to cause
major organ system toxicity during the past four weeks; other cholinergic drugs (e.g.,
donepezil, tacrine, succinylcholine-type muscle relaxants) during the past two weeks
(topical pilocarpine will be permitted); antidepressant medication during the past
four weeks.

- Participated in a previous clinical trial of Exelon.

- Clinically important laboratory abnormalities in serum B12, folate, or T3/T4 at
screening. The subject should be excluded if peripheral neuropathy, macrocytic anemia,
or myxedema is present.

- If screen values do not meet the absolutely exclusionary values given below but are
still outside the normal reference range, treatment for folic acid/B12 deficiency or
thyroid disorder, as appropriate, may be initiated or adjusted with re-evaluation of
the subject within three months. Within these three months of treatment, the subject's
cognitive condition must be clinically unchanged or worse for the subject to be
acceptable. Once accepted, the subject must remain on the appropriate treatment
throughout the study.

- Exclude if T3 uptake is less than 19%; T4 less than 2.9 ((g/dL); free T4 index is less
than 0.8

- Exclude if folate less than 1.7 ng/ml (normal range greater than 1.9)

- Exclude if B12 less than 100 pg/ml (normal range greater than 200)

- A positive rapid plasmin reagin test followed up by a positive serological test for
syphilis.

- A disability that may prevent the subject from completing all study requirements
(e.g., blindness, deafness, severe language difficulty).
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>55 Years</minimum_age>
<maximum_age>85 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Steven Ferris, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>NYU Langone Health</affiliation>
</overall_official>
<location>
<facility>
<name>Medici Research Centers</name>
<address>
<city>Peoria</city>
<state>Arizona</state>
<zip>85381</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, Irvine</name>
<address>
<city>Orange</city>
<state>California</state>
<zip>92868</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Colorado Health Sciences Center</name>
<address>
<city>Denver</city>
<state>Colorado</state>
<zip>80220</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)</name>
<address>
<city>Ft. Lauderdale</city>
<state>Florida</state>
<zip>33321</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Miami Research Associates</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33176</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Center for Clinical Trials and Research</name>
<address>
<city>Venice</city>
<state>Florida</state>
<zip>34285</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University Alzheimer's Center</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Louis University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Alzheimer's Research Corporation</name>
<address>
<city>Lakewood</city>
<state>New Jersey</state>
<zip>08701</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>NYU Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University Medical Center</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<zip>27710</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Pahl Brain Associates, P.C.</name>
<address>
<city>Oklahoma City</city>
<state>Oklahoma</state>
<zip>73118</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinical Studies, Ltd., Philadelphia</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19106</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Paul Medical Center</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75235</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Washington, Seattle</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98108</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.alzheimers.org</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).</description>
</link>
<verification_date>January 2000</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Mild cognitive impairment</keyword>
<keyword>Alzheimer's disease</keyword>
<keyword>Memory</keyword>
<keyword>Cholinergic agents</keyword>
<keyword>Cholinesterase inhibitors</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
<mesh_term>Cognition Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Rivastigmine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000174
org study id: IA0012
nct id: NCT00000174
lead sponsor:
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled,
36-month study comparing the length of time of progression from mild cognitive impairment
(MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs.
placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a
treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40
countries for Alzheimer's disease to date, including all 15 member states of the European
Union, New Zealand, Argentina, Brazil and Mexico.
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo.
Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day)
for the majority of the study. At every regular visit scheduled every three months, patients
will be given basic efficacy and safety assessments. These assessments will include
evaluation of adverse events, vital signs, activities of daily living, and clinical staging
scales to determine if the subject may have converted to dementia.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Rivastigmine
criteria:
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Steven Ferris, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.alzheimers.org
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).
mesh term: Alzheimer Disease
mesh term: Cognition Disorders
mesh term: Rivastigmine
|
NCT0000xxxx/NCT00000175.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000175</url>
</required_header>
<id_info>
<org_study_id>IA0016</org_study_id>
<nct_id>NCT00000175</nct_id>
</id_info>
<brief_title>The Effects of Sex Hormones on Cognition and Mood in Older Adults</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
This study is investigating the effects of hormone replacement therapy on memory, mental
abilities and mood in older adults aged 65-90. During the nine month long study, men will
take testosterone for three months and women will take estrogen for three months. At four
points during the study (once every three months), participants will complete a test battery
and have blood drawn.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
Double-blind, placebo-controlled, crossover study investigating the effects of estrogen
replacement and testosterone replacement on cognition and mood in older adults. Women who
have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the
uterine lining), and hysterectomized women will be given Premarin (estrogen only).
</textblock>
</detailed_description>
<overall_status>Terminated</overall_status>
<completion_date type="Anticipated">June 2005</completion_date>
<primary_completion_date type="Anticipated">June 2005</primary_completion_date>
<phase>N/A</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Cognition Disorders</condition>
<condition>Mood Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Estrogen</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Testosterone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Women and men aged 65-90 who have not received hormone replacement for the last three
months.

Exclusion Criteria:

- Previous head injury with loss of consciousness for more than one hour.

- Men with a history of prostate cancer.

- Men on testosterone replacement within the past three months.

- Women with a history of breast or uterine cancer.

- Women on estrogen replacement within the past three months.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>90 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Dr. Pauline Maki</last_name>
<role>Principal Investigator</role>
<affiliation>National Institute on Aging, Gerontology Research Center</affiliation>
</overall_official>
<location>
<facility>
<name>Gerontology Research Center</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.</citation>
<PMID>9153164</PMID>
</reference>
<reference>
<citation>Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.</citation>
<PMID>8037876</PMID>
</reference>
<reference>
<citation>Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.</citation>
<PMID>9153163</PMID>
</reference>
<verification_date>March 2004</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>December 10, 2009</last_update_submitted>
<last_update_submitted_qc>December 10, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">December 11, 2009</last_update_posted>
<keyword>Emotions</keyword>
<keyword>Cognition</keyword>
<keyword>Aging</keyword>
<keyword>Memory</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Mood Disorders</mesh_term>
<mesh_term>Cognition Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Testosterone</mesh_term>
<mesh_term>Estrogens</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000175
org study id: IA0016
nct id: NCT00000175
lead sponsor:
This study is investigating the effects of hormone replacement therapy on memory, mental
abilities and mood in older adults aged 65-90. During the nine month long study, men will
take testosterone for three months and women will take estrogen for three months. At four
points during the study (once every three months), participants will complete a test battery
and have blood drawn.
Double-blind, placebo-controlled, crossover study investigating the effects of estrogen
replacement and testosterone replacement on cognition and mood in older adults. Women who
have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the
uterine lining), and hysterectomized women will be given Premarin (estrogen only).
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Estrogen
intervention type: Drug
intervention name: Testosterone
criteria:
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Pauline Maki
role: Principal Investigator
affiliation: National Institute on Aging, Gerontology Research Center
facility:
country: United States
citation: Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.
PMID: 9153164
citation: Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.
PMID: 8037876
citation: Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.
PMID: 9153163
mesh term: Mood Disorders
mesh term: Cognition Disorders
mesh term: Testosterone
mesh term: Estrogens
|
NCT0000xxxx/NCT00000176.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000176</url>
</required_header>
<id_info>
<org_study_id>IA0018</org_study_id>
<secondary_id>RO 1AG15922-01</secondary_id>
<nct_id>NCT00000176</nct_id>
</id_info>
<brief_title>Alzheimer's Disease Prevention Trial</brief_title>
<official_title>Alzheimer's Disease Prevention Trial. A Multi-center, Randomized, Double-blind Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women.</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's
disease in women with a family history of Alzheimer's disease.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is
a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and
progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with
a family history of the disease.
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<completion_date type="Actual">September 2007</completion_date>
<primary_completion_date type="Actual">September 2007</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Prevention</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<condition>Memory Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Estrogen</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Estrogen and Progesterone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Healthy women 65 or older with a family history of memory problems not currently on
estrogen.

Exclusion Criteria:

- Significant neurological impairment

- Current estrogen use

- History of breast cancer
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>65 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Mary Sano, PhD</last_name>
<role>Principal Investigator</role>
<affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
</overall_official>
<location>
<facility>
<name>University of Alabama</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, Irvine</name>
<address>
<city>Irvine</city>
<state>California</state>
<zip>29697-4540</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New England Center for Headache</name>
<address>
<city>Stamford</city>
<state>Connecticut</state>
<zip>06902-1249</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Howard University</name>
<address>
<city>Washington</city>
<state>District of Columbia</state>
<zip>20060</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Lee Memorial Health System</name>
<address>
<city>Fort Myers</city>
<state>Florida</state>
<zip>33901</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Wein Center</name>
<address>
<city>Miami Beach</city>
<state>Florida</state>
<zip>33140</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>West Florida Regional Medical Center</name>
<address>
<city>Pensacola</city>
<state>Florida</state>
<zip>32514</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>North Broward Medical Center</name>
<address>
<city>Pompano Beach</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Tallahassee Memorial Health Center</name>
<address>
<city>Tallahassee</city>
<state>Florida</state>
<zip>32308</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>St. Mary's Medical Center</name>
<address>
<city>West Palm Beach</city>
<state>Florida</state>
<zip>33407</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins Bayview Medical Center</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Neurology Group of Bergen County</name>
<address>
<city>Ridgewood</city>
<state>New Jersey</state>
<zip>07450</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Cornell Medical Center, New York Presbyterian Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York United Hospital Medical Center</name>
<address>
<city>Port Chester</city>
<state>New York</state>
<zip>10573</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Burke Medical Research Institute</name>
<address>
<city>White Plains</city>
<state>New York</state>
<zip>10605</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Duke University Medical Center</name>
<address>
<city>Durham</city>
<state>North Carolina</state>
<zip>27710</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Clinical Pharmaceutical Trials</name>
<address>
<city>Tulsa</city>
<state>Oklahoma</state>
<zip>74104-5428</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Butler Hospital, Rhode Island Hospital</name>
<address>
<city>Providence</city>
<state>Rhode Island</state>
<zip>02906</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Medical University of South Carolina</name>
<address>
<city>North Charleston</city>
<state>South Carolina</state>
<zip>29406</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Eastern Virginia Medical School</name>
<address>
<city>Norfolk</city>
<state>Virginia</state>
<zip>23507-1912</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. doi: 10.1016/S0140-6736(96)03356-9.</citation>
<PMID>8709781</PMID>
</reference>
<reference>
<citation>Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. doi: 10.1212/wnl.48.6.1517. Erratum In: Neurology 1998 Aug;51(2):654.</citation>
<PMID>9191758</PMID>
</reference>
<reference>
<citation>Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. doi: 10.1212/wnl.50.2.368.</citation>
<PMID>9484355</PMID>
</reference>
<results_reference>
<citation>Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75.</citation>
<PMID>17195882</PMID>
</results_reference>
<verification_date>November 2010</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>November 3, 2010</last_update_submitted>
<last_update_submitted_qc>November 3, 2010</last_update_submitted_qc>
<last_update_posted type="Estimate">November 5, 2010</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>memory loss</keyword>
<keyword>Estrogen</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
<mesh_term>Memory Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Progesterone</mesh_term>
<mesh_term>Estrogens</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000176
org study id: IA0018
secondary id: RO 1AG15922-01
nct id: NCT00000176
lead sponsor:
This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's
disease in women with a family history of Alzheimer's disease.
PREventing Postmenopausal memory loss and Alzheimer's with Replacement Estrogens (PREPARE) is
a double-blind-placebo controlled trial to determine whether estrogen (or estrogen and
progesterone) can delay the onset of memory loss or Alzheimer's Disease in elderly women with
a family history of the disease.
allocation: Randomized
primary purpose: Prevention
masking: Double
intervention type: Drug
intervention name: Estrogen
intervention type: Drug
intervention name: Estrogen and Progesterone
criteria:
gender: Female
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Sano, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
citation: Tang MX, Jacobs D, Stern Y, Marder K, Schofield P, Gurland B, Andrews H, Mayeux R. Effect of oestrogen during menopause on risk and age at onset of Alzheimer's disease. Lancet. 1996 Aug 17;348(9025):429-32. doi: 10.1016/S0140-6736(96)03356-9.
PMID: 8709781
citation: Kawas C, Resnick S, Morrison A, Brookmeyer R, Corrada M, Zonderman A, Bacal C, Lingle DD, Metter E. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer's disease: the Baltimore Longitudinal Study of Aging. Neurology. 1997 Jun;48(6):1517-21. doi: 10.1212/wnl.48.6.1517. Erratum In: Neurology 1998 Aug;51(2):654.
PMID: 9191758
citation: Jacobs DM, Tang MX, Stern Y, Sano M, Marder K, Bell KL, Schofield P, Dooneief G, Gurland B, Mayeux R. Cognitive function in nondemented older women who took estrogen after menopause. Neurology. 1998 Feb;50(2):368-73. doi: 10.1212/wnl.50.2.368.
PMID: 9484355
citation: Aloysi A, Van Dyk K, Sano M. Women's cognitive and affective health and neuropsychiatry. Mt Sinai J Med. 2006 Nov;73(7):967-75.
PMID: 17195882
mesh term: Alzheimer Disease
mesh term: Memory Disorders
mesh term: Progesterone
mesh term: Estrogens
|
NCT0000xxxx/NCT00000177.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000177</url>
</required_header>
<id_info>
<org_study_id>IA0001</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000177</nct_id>
</id_info>
<brief_title>Estrogen Hormone Protocol</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
Estrogen is a hormone that is dominant in the female reproductive system. In women, most
estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into
estrogen. Because this hormone also has many beneficial effects on brain cells, it currently
is being studied as a treatment for Alzheimer's disease. The enzyme that forms the
neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small
clinical studies have demonstrated improvement in cognitive function and mood measures in
women with Alzheimer's disease who take estrogen.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>October 1995</start_date>
<completion_date type="Actual">January 1999</completion_date>
<primary_completion_date type="Actual">January 1999</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<enrollment>120</enrollment>
<condition>Alzheimer Disease</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Estrogen</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen
replacement therapy, who have had a hysterectomy, and who are in stable general
health.

Exclusion Criteria:

- Patients with an uncontrolled health problem, such as untreated high blood pressure or
thyroid disease.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>60 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Leon Thal, MD.</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, San Diego</affiliation>
</overall_official>
<location>
<facility>
<name>University of Alabama, Birmingham</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294-0017</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30329</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Rush Presbyterian St. Luke's Medical Center</name>
<address>
<city>Chicago</city>
<state>Illinois</state>
<zip>60612</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southern Illinois University</name>
<address>
<city>Springfield</city>
<state>Illinois</state>
<zip>62702</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University Medical Center</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202-5266</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kansas Medical Center</name>
<address>
<city>Kansas City</city>
<state>Kansas</state>
<zip>66160</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kentucky</name>
<address>
<city>Lexington</city>
<state>Kentucky</state>
<zip>40536-0230</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Massachusetts General Hospital</name>
<address>
<city>Boston</city>
<state>Massachusetts</state>
<zip>02114</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic</name>
<address>
<city>Rochester</city>
<state>Minnesota</state>
<zip>55901-0144</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai School of Medicine</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia Presbyterian Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>11032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Burke Medical Research Institute</name>
<address>
<city>White Plains</city>
<state>New York</state>
<zip>10605</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Hospitals of Cleveland</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44120</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pittsburgh</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15213</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75235</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Baylor College of Medicine</name>
<address>
<city>Houston</city>
<state>Texas</state>
<zip>77030</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Washington</name>
<address>
<city>Seattle</city>
<state>Washington</state>
<zip>98195</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.adcs.org/</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).</description>
</link>
<results_reference>
<citation>Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal LJ. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000 Feb 23;283(8):1007-15. doi: 10.1001/jama.283.8.1007. Erratum In: JAMA 2000 Nov 22-29;284(20):2597.</citation>
<PMID>10697060</PMID>
</results_reference>
<verification_date>September 2009</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>December 10, 2009</last_update_submitted>
<last_update_submitted_qc>December 10, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">December 11, 2009</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>Estrogen</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Estrogens</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000177
org study id: IA0001
secondary id: 3U01AG010483-08S2
nct id: NCT00000177
lead sponsor:
Estrogen is a hormone that is dominant in the female reproductive system. In women, most
estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into
estrogen. Because this hormone also has many beneficial effects on brain cells, it currently
is being studied as a treatment for Alzheimer's disease. The enzyme that forms the
neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small
clinical studies have demonstrated improvement in cognitive function and mood measures in
women with Alzheimer's disease who take estrogen.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Estrogen
criteria:
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Leon Thal, MD.
role: Principal Investigator
affiliation: University of California, San Diego
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.adcs.org/
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).
citation: Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal LJ. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000 Feb 23;283(8):1007-15. doi: 10.1001/jama.283.8.1007. Erratum In: JAMA 2000 Nov 22-29;284(20):2597.
PMID: 10697060
mesh term: Alzheimer Disease
mesh term: Estrogens
|
NCT0000xxxx/NCT00000178.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000178</url>
</required_header>
<id_info>
<org_study_id>IA0002</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000178</nct_id>
</id_info>
<brief_title>Multicenter Trial of Prednisone in Alzheimer's Disease</brief_title>
<official_title>Multicenter Trial of Prednisone in Alzheimer's Disease</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
This is a randomized placebo controlled, double blind study. Patients who meet eligibility
criteria and decide to participate in the study will be randomly assigned to receive either
drug treatment or a placebo. Neither the patients nor the participating investigators will
know who is receiving the drugs and who is receiving the placebo. Participation involves 15
outpatient clinic visits over a 68 week period. Patients take study medication at varying
doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Prednisone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Patients with Alzheimer's disease who are in stable medical condition

Exclusion Criteria:

- Patients with diabetes or severe osteoporosis
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>0 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Leon Thal, MD.</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, San Diego</affiliation>
</overall_official>
<location>
<facility>
<name>University of Alabama, Birmingham</name>
<address>
<city>Birmingham</city>
<state>Alabama</state>
<zip>35294-0017</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Southern California</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90033</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093-0949</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mayo Clinic Jacksonville</name>
<address>
<city>Jacksonville</city>
<state>Florida</state>
<zip>32225</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Miami</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33140</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33162</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University Alzheimer's Center</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kansas Medical Center</name>
<address>
<city>Kansas City</city>
<state>Kansas</state>
<zip>66160</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Johns Hopkins University</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Columbia Presbyterian Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>11032</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Rochester</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Burke Medical Research Institute</name>
<address>
<city>White Plains</city>
<state>New York</state>
<zip>10605</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Pittsburgh</name>
<address>
<city>Pittsburgh</city>
<state>Pennsylvania</state>
<zip>15213</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Vanderbilt University Medical Center</name>
<address>
<city>Nashville</city>
<state>Tennessee</state>
<zip>37212-8646</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Texas</name>
<address>
<city>Dallas</city>
<state>Texas</state>
<zip>75235-9070</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.alzheimers.org</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).</description>
</link>
<results_reference>
<citation>Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, Weiner MF, Farlow MR, Sano M, Grundman M, Thal LJ. A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. 2000 Feb 8;54(3):588-93. doi: 10.1212/wnl.54.3.588.</citation>
<PMID>10680787</PMID>
</results_reference>
<verification_date>February 2005</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>Prednisone</keyword>
<keyword>Anti-inflammatory agents</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Prednisone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000178
org study id: IA0002
secondary id: 3U01AG010483-08S2
nct id: NCT00000178
lead sponsor:
This is a randomized placebo controlled, double blind study. Patients who meet eligibility
criteria and decide to participate in the study will be randomly assigned to receive either
drug treatment or a placebo. Neither the patients nor the participating investigators will
know who is receiving the drugs and who is receiving the placebo. Participation involves 15
outpatient clinic visits over a 68 week period. Patients take study medication at varying
doses (the maximum dose is 20 mg daily), along with calcium and vitamin supplements.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Prednisone
criteria:
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
last name: Leon Thal, MD.
role: Principal Investigator
affiliation: University of California, San Diego
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.alzheimers.org
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA).
citation: Aisen PS, Davis KL, Berg JD, Schafer K, Campbell K, Thomas RG, Weiner MF, Farlow MR, Sano M, Grundman M, Thal LJ. A randomized controlled trial of prednisone in Alzheimer's disease. Alzheimer's Disease Cooperative Study. Neurology. 2000 Feb 8;54(3):588-93. doi: 10.1212/wnl.54.3.588.
PMID: 10680787
mesh term: Alzheimer Disease
mesh term: Prednisone
|
NCT0000xxxx/NCT00000179.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000179</url>
</required_header>
<id_info>
<org_study_id>IA0003</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000179</nct_id>
</id_info>
<brief_title>Agitation in Alzheimer's Disease</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and
physical aggressiveness, irritability, wandering, and restlessness. These behaviors often
make caring for patients at home very difficult. Trazodone and haldol are two of the most
commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug
approach, has been effective in reducing signs of agitation. Researchers have yet to compare
the effectiveness of drug versus non drug therapy to treat agitation in AD patients and
determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with
funding from the National Institute on Aging, is conducting an agitation treatment program at
21 sites in 16 States. This study will assess which of the above treatments is most
effective.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Alzheimer Disease</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Trazodone</intervention_name>
</intervention>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Haloperidol</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

- Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)

- Agitation symptoms for at least the past 2 weeks

- Patient has caregiver who can participate

- Patient lives in the same household as the caregiver
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>50 Years</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Leon Thal, MD.</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, San Diego</affiliation>
</overall_official>
<location>
<facility>
<name>University of California, Los Angeles</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90095</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093-0949</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Miami</name>
<address>
<city>Miami</city>
<state>Florida</state>
<zip>33140</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of South Florida</name>
<address>
<city>Tampa</city>
<state>Florida</state>
<zip>33162</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Emory University</name>
<address>
<city>Atlanta</city>
<state>Georgia</state>
<zip>30329</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Southern Illinois University</name>
<address>
<city>Springfield</city>
<state>Illinois</state>
<zip>62702</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kansas Medical Center</name>
<address>
<city>Kansas City</city>
<state>Kansas</state>
<zip>66160</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Kentucky</name>
<address>
<city>Lexington</city>
<state>Kentucky</state>
<zip>40536</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Massachusetts</name>
<address>
<city>Worcester</city>
<state>Massachusetts</state>
<zip>01665</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Minnesota</name>
<address>
<city>Minneapolis</city>
<state>Minnesota</state>
<zip>55455</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>New York University Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10016</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Mount Sinai Medical Center</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10029</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Rochester</name>
<address>
<city>Rochester</city>
<state>New York</state>
<zip>14620</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University Hospitals of Cleveland</name>
<address>
<city>Cleveland</city>
<state>Ohio</state>
<zip>44120</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Oregon Health Sciences University</name>
<address>
<city>Portland</city>
<state>Oregon</state>
<zip>97201-3098</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<link>
<url>http://www.alzheimers.org/</url>
<description>The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)</description>
</link>
<results_reference>
<citation>Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in AD: a randomized, placebo-controlled clinical trial. Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271. Erratum In: Neurology 2001 Feb 13;56(3):426.</citation>
<PMID>11087767</PMID>
</results_reference>
<verification_date>March 2005</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>June 23, 2005</last_update_submitted>
<last_update_submitted_qc>June 23, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">June 24, 2005</last_update_posted>
<keyword>Alzheimer's disease</keyword>
<keyword>Psychomotor agitation</keyword>
<keyword>Behavioral symptoms</keyword>
<keyword>Haloperidol</keyword>
<keyword>Trazodone</keyword>
<keyword>Anti-psychotic agents</keyword>
<keyword>Anti-depressant agents</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Alzheimer Disease</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Haloperidol</mesh_term>
<mesh_term>Haloperidol decanoate</mesh_term>
<mesh_term>Trazodone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000179
org study id: IA0003
secondary id: 3U01AG010483-08S2
nct id: NCT00000179
lead sponsor:
Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and
physical aggressiveness, irritability, wandering, and restlessness. These behaviors often
make caring for patients at home very difficult. Trazodone and haldol are two of the most
commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug
approach, has been effective in reducing signs of agitation. Researchers have yet to compare
the effectiveness of drug versus non drug therapy to treat agitation in AD patients and
determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with
funding from the National Institute on Aging, is conducting an agitation treatment program at
21 sites in 16 States. This study will assess which of the above treatments is most
effective.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: Trazodone
intervention type: Drug
intervention name: Haloperidol
criteria:
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Leon Thal, MD.
role: Principal Investigator
affiliation: University of California, San Diego
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
facility:
country: United States
url: http://www.alzheimers.org/
description: The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)
citation: Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in AD: a randomized, placebo-controlled clinical trial. Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271. Erratum In: Neurology 2001 Feb 13;56(3):426.
PMID: 11087767
mesh term: Alzheimer Disease
mesh term: Haloperidol
mesh term: Haloperidol decanoate
mesh term: Trazodone
|
NCT0000xxxx/NCT00000180.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000180</url>
</required_header>
<id_info>
<org_study_id>IA0008</org_study_id>
<secondary_id>3U01AG010483-08S2</secondary_id>
<nct_id>NCT00000180</nct_id>
</id_info>
<brief_title>AIT-082 Phase 1B Study</brief_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Aging (NIA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Aging (NIA)</source>
<brief_summary>
<textblock>
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve
function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting
in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged
animals and in animals with neurological deficits.

This study was a double-blind placebo-controlled safety study that was designed to study
whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two
clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks;
were tested for side effects and absorption; and underwent a battery of neuropsychological
memory tests, including word and number recall tests.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<completion_date type="Actual">June 2005</completion_date>
<primary_completion_date type="Actual">June 2005</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<condition>Memory Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>AIT-082</intervention_name>
</intervention>
<eligibility>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Michael Grundman, M.D., M.P.H.</last_name>
<role>Principal Investigator</role>
<affiliation>University of California, San Diego</affiliation>
</overall_official>
<location>
<facility>
<name>University of California, San Diego</name>
<address>
<city>San Diego</city>
<state>California</state>
<zip>92093-0949</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Indiana University Alzheimer's Center</name>
<address>
<city>Indianapolis</city>
<state>Indiana</state>
<zip>46202</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>University of Michigan</name>
<address>
<city>Ann Arbor</city>
<state>Michigan</state>
<zip>48109-0322</zip>
<country>United States</country>
</address>
</facility>
</location>
<location>
<facility>
<name>Washington University</name>
<address>
<city>St. Louis</city>
<state>Missouri</state>
<zip>63110</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<results_reference>
<citation>Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5.</citation>
<PMID>12770610</PMID>
</results_reference>
<verification_date>February 2005</verification_date>
<study_first_submitted>October 29, 1999</study_first_submitted>
<study_first_submitted_qc>October 29, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">November 1, 1999</study_first_posted>
<last_update_submitted>December 10, 2009</last_update_submitted>
<last_update_submitted_qc>December 10, 2009</last_update_submitted_qc>
<last_update_posted type="Estimate">December 11, 2009</last_update_posted>
<keyword>Memory</keyword>
<keyword>Mild cognitive impairment</keyword>
<keyword>Nerve growth factors</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Memory Disorders</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000180
org study id: IA0008
secondary id: 3U01AG010483-08S2
nct id: NCT00000180
lead sponsor:
AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve
function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting
in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged
animals and in animals with neurological deficits.
This study was a double-blind placebo-controlled safety study that was designed to study
whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two
clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks;
were tested for side effects and absorption; and underwent a battery of neuropsychological
memory tests, including word and number recall tests.
allocation: Randomized
primary purpose: Treatment
masking: Double
intervention type: Drug
intervention name: AIT-082
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Grundman, M.D., M.P.H.
role: Principal Investigator
affiliation: University of California, San Diego
facility:
facility:
facility:
facility:
country: United States
citation: Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53. doi: 10.1016/s0024-3205(03)00320-5.
PMID: 12770610
mesh term: Memory Disorders
|
NCT0000xxxx/NCT00000187.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000187</url>
</required_header>
<id_info>
<org_study_id>NIDA-00144-1</org_study_id>
<secondary_id>3R01DA012268</secondary_id>
<secondary_id>K20-00144-1</secondary_id>
<nct_id>NCT00000187</nct_id>
</id_info>
<brief_title>Ritanserin in Treatment of Cocaine Dependence - 1</brief_title>
<official_title>Ritanserin in Treatment of Cocaine Dependence</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine
dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>July 1992</start_date>
<primary_completion_date type="Actual">June 1994</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Cocaine use</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine craving</measure>
</primary_outcome>
<enrollment type="Actual">80</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Ritanserin</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>28 Years</minimum_age>
<maximum_age>47 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>James Cornish, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.</citation>
<PMID>11137283</PMID>
</reference>
<verification_date>May 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 26, 2015</last_update_submitted>
<last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">May 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>James Cornish</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Cocaine Dependence</keyword>
<keyword>ritanserin</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Ritanserin</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000187
org study id: NIDA-00144-1
secondary id: 3R01DA012268
secondary id: K20-00144-1
nct id: NCT00000187
lead sponsor:
collaborator:
The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine
dependence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cocaine use
measure: Cocaine craving
intervention type: Drug
intervention name: Ritanserin
criteria:
gender: Male
minimum age: 28 Years
maximum age: 47 Years
healthy volunteers: No
last name: James Cornish, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
citation: Cornish JW, Maany I, Fudala PJ, Ehrman RN, Robbins SJ, O'Brien CP. A randomized, double-blind, placebo-controlled study of ritanserin pharmacotherapy for cocaine dependence. Drug Alcohol Depend. 2001 Jan 1;61(2):183-9. doi: 10.1016/s0376-8716(00)00140-x.
PMID: 11137283
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: James Cornish
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
mesh term: Ritanserin
|
NCT0000xxxx/NCT00000188.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000188</url>
</required_header>
<id_info>
<org_study_id>NIDA-00144-2</org_study_id>
<secondary_id>3R01DA012268</secondary_id>
<secondary_id>K20-00144-2</secondary_id>
<nct_id>NCT00000188</nct_id>
</id_info>
<brief_title>Selegiline in Treatment of Cocaine Dependence - 2</brief_title>
<official_title>Selegiline in Treatment of Cocaine Dependence</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine
dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>September 1994</start_date>
<completion_date type="Actual">October 1995</completion_date>
<primary_completion_date type="Actual">October 1995</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<primary_outcome>
<measure>Retention</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine use</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine craving</measure>
</primary_outcome>
<enrollment type="Actual">50</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Selegiline</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>James Cornish, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>PDVAMC Treatment Research Center</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 26, 2015</last_update_submitted>
<last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">May 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>James Cornish</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Cocaine Dependence</keyword>
<keyword>Selegiline</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Selegiline</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000188
org study id: NIDA-00144-2
secondary id: 3R01DA012268
secondary id: K20-00144-2
nct id: NCT00000188
lead sponsor:
collaborator:
The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine
dependence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Retention
measure: Cocaine use
measure: Cocaine craving
intervention type: Drug
intervention name: Selegiline
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: James Cornish, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: James Cornish
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
mesh term: Selegiline
|
NCT0000xxxx/NCT00000189.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000189</url>
</required_header>
<id_info>
<org_study_id>NIDA-00144-3</org_study_id>
<secondary_id>3R01DA012268</secondary_id>
<secondary_id>K20-00144-3</secondary_id>
<nct_id>NCT00000189</nct_id>
</id_info>
<brief_title>Gepirone vs Placebo in Treatment of Cocaine Dependence - 3</brief_title>
<official_title>Gepirone vs Placebo in Treatment of Cocaine Dependence</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to test antidepressant medication, gepirone, as a
pharmacotherapy for cocaine dependent subjects.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>January 1990</start_date>
<completion_date type="Actual">February 1991</completion_date>
<primary_completion_date type="Actual">February 1991</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<intervention_model>Parallel Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Investigator)</masking>
</study_design_info>
<enrollment type="Actual">41</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Gepirone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>James Cornish, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Jenkins SW, Warfield NA, Blaine JD, Cornish J, Ling W, Rosen MI, Urschel H 3rd, Wesson D, Ziedonis D. A pilot trial of gepirone vs. placebo in the treatment of cocaine dependency. Psychopharmacol Bull. 1992;28(1):21-6.</citation>
<PMID>1609038</PMID>
</reference>
<verification_date>May 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 26, 2015</last_update_submitted>
<last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">May 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>James Cornish</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Cocaine Dependence</keyword>
<keyword>Gepirone</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Gepirone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000189
org study id: NIDA-00144-3
secondary id: 3R01DA012268
secondary id: K20-00144-3
nct id: NCT00000189
lead sponsor:
collaborator:
The purpose of this study is to test antidepressant medication, gepirone, as a
pharmacotherapy for cocaine dependent subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
intervention type: Drug
intervention name: Gepirone
criteria:
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: James Cornish, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
citation: Jenkins SW, Warfield NA, Blaine JD, Cornish J, Ling W, Rosen MI, Urschel H 3rd, Wesson D, Ziedonis D. A pilot trial of gepirone vs. placebo in the treatment of cocaine dependency. Psychopharmacol Bull. 1992;28(1):21-6.
PMID: 1609038
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: James Cornish
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
mesh term: Gepirone
|
NCT0000xxxx/NCT00000190.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000190</url>
</required_header>
<id_info>
<org_study_id>NIDA-00144-4</org_study_id>
<secondary_id>3R01DA012268</secondary_id>
<secondary_id>K20-00144-4</secondary_id>
<nct_id>NCT00000190</nct_id>
</id_info>
<brief_title>Cocaine in Parotid Saliva, Blood and Urine - 4</brief_title>
<official_title>Cocaine in Parotid Saliva, Blood and Urine</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to establish the use of parotid saliva as a means of detecting
and quantifying cocaine and its metabolites.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>January 1991</start_date>
<completion_date type="Actual">February 1992</completion_date>
<primary_completion_date type="Actual">February 1992</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Diagnostic</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Cocaine & benzoylecgonine content in saliva, plasma, & urine</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Procedure</intervention_type>
<intervention_name>Parotid Gland</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>James Cornish, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>May 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 26, 2015</last_update_submitted>
<last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">May 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>James Cornish</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Cocaine Detection</keyword>
<keyword>Parotid Saliva</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000190
org study id: NIDA-00144-4
secondary id: 3R01DA012268
secondary id: K20-00144-4
nct id: NCT00000190
lead sponsor:
collaborator:
The purpose of this study is to establish the use of parotid saliva as a means of detecting
and quantifying cocaine and its metabolites.
primary purpose: Diagnostic
measure: Cocaine & benzoylecgonine content in saliva, plasma, & urine
intervention type: Procedure
intervention name: Parotid Gland
criteria:
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: James Cornish, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: James Cornish
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
|
NCT0000xxxx/NCT00000191.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000191</url>
</required_header>
<id_info>
<org_study_id>NIDA-00144-5</org_study_id>
<secondary_id>3R01DA012268</secondary_id>
<secondary_id>K20-00144-5</secondary_id>
<nct_id>NCT00000191</nct_id>
</id_info>
<brief_title>Carbamazepine Treatment for Cocaine Dependence - 5</brief_title>
<official_title>Carbamazepine Treatment for Cocaine Dependence</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine
dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>January 1991</start_date>
<completion_date type="Actual">February 1994</completion_date>
<primary_completion_date type="Actual">February 1994</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Carbamazepine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>51 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>James Cornish, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Cornish JW, Maany I, Fudala PJ, Neal S, Poole SA, Volpicelli P, O'Brien CP. Carbamazepine treatment for cocaine dependence. Drug Alcohol Depend. 1995 Jun;38(3):221-7. doi: 10.1016/0376-8716(95)01102-5.</citation>
<PMID>7555622</PMID>
</reference>
<verification_date>May 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 26, 2015</last_update_submitted>
<last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">May 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>James Cornish</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>Cocaine Dependence</keyword>
<keyword>Carbamazepine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Carbamazepine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000191
org study id: NIDA-00144-5
secondary id: 3R01DA012268
secondary id: K20-00144-5
nct id: NCT00000191
lead sponsor:
collaborator:
The purpose of this study is to assess carbamazepine as a pharmacotherapy for cocaine
dependence.
primary purpose: Treatment
intervention type: Drug
intervention name: Carbamazepine
criteria:
gender: All
minimum age: 21 Years
maximum age: 51 Years
healthy volunteers: No
last name: James Cornish, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
citation: Cornish JW, Maany I, Fudala PJ, Neal S, Poole SA, Volpicelli P, O'Brien CP. Carbamazepine treatment for cocaine dependence. Drug Alcohol Depend. 1995 Jun;38(3):221-7. doi: 10.1016/0376-8716(95)01102-5.
PMID: 7555622
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: James Cornish
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
mesh term: Carbamazepine
|
NCT0000xxxx/NCT00000192.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000192</url>
</required_header>
<id_info>
<org_study_id>NIDA-00191-1</org_study_id>
<secondary_id>K20DA000191</secondary_id>
<secondary_id>K20-00191-1</secondary_id>
<nct_id>NCT00000192</nct_id>
</id_info>
<brief_title>Neurobiology of Opioid Dependence: 1 - 1</brief_title>
<official_title>Neurobiology of Opioid Dependence: 1</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated
opiate withdrawal.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<start_date>January 1993</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal</measure>
</primary_outcome>
<primary_outcome>
<measure>Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Lamotrigine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marc I Rosen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Rosen MI, Pearsall HR, Kosten TR. The effect of lamotrigine on naloxone-precipitated opiate withdrawal. Drug Alcohol Depend. 1998 Oct 1;52(2):173-6. doi: 10.1016/s0376-8716(98)00057-x.</citation>
<PMID>9800147</PMID>
</reference>
<verification_date>August 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 5, 2015</last_update_submitted>
<last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">August 7, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>opioid disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Lamotrigine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000192
org study id: NIDA-00191-1
secondary id: K20DA000191
secondary id: K20-00191-1
nct id: NCT00000192
lead sponsor:
collaborator:
The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated
opiate withdrawal.
primary purpose: Treatment
masking: Double
measure: Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal
measure: Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal
intervention type: Drug
intervention name: Lamotrigine
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc I Rosen, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
citation: Rosen MI, Pearsall HR, Kosten TR. The effect of lamotrigine on naloxone-precipitated opiate withdrawal. Drug Alcohol Depend. 1998 Oct 1;52(2):173-6. doi: 10.1016/s0376-8716(98)00057-x.
PMID: 9800147
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Lamotrigine
|
NCT0000xxxx/NCT00000193.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000193</url>
</required_header>
<id_info>
<org_study_id>NIDA-00191-2</org_study_id>
<secondary_id>K20DA000191</secondary_id>
<secondary_id>K20-00191-2</secondary_id>
<nct_id>NCT00000193</nct_id>
</id_info>
<brief_title>Neurobiology of Opioid Dependence: 2 - 2</brief_title>
<official_title>Neurobiology of Opioid Dependence: 2</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of gamma hydroxybutyric on
naloxone-precipitated opiate withdrawal.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<start_date>January 1993</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Behavioral, subjective, measures of naloxone-preci</measure>
</primary_outcome>
<primary_outcome>
<measure>Phsyiological, neuroendocrine measures of naloxone</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Gamma hydroxybutyric</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marc I Rosen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Neuropsychopharmacology, 1996; 14(3) pp 187-193. Neruopsychopharmacology 1996; 14(3), 187-193</citation>
</reference>
<verification_date>August 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 5, 2015</last_update_submitted>
<last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">August 7, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Opioid disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000193
org study id: NIDA-00191-2
secondary id: K20DA000191
secondary id: K20-00191-2
nct id: NCT00000193
lead sponsor:
collaborator:
The purpose of this study is to evaluate the effects of gamma hydroxybutyric on
naloxone-precipitated opiate withdrawal.
primary purpose: Treatment
masking: Double
measure: Behavioral, subjective, measures of naloxone-preci
measure: Phsyiological, neuroendocrine measures of naloxone
intervention type: Drug
intervention name: Gamma hydroxybutyric
criteria:
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc I Rosen, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
citation: Neuropsychopharmacology, 1996; 14(3) pp 187-193. Neruopsychopharmacology 1996; 14(3), 187-193
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
|
NCT0000xxxx/NCT00000194.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000194</url>
</required_header>
<id_info>
<org_study_id>NIDA-00191-3</org_study_id>
<secondary_id>K20DA000191</secondary_id>
<secondary_id>K20-00191-3</secondary_id>
<nct_id>NCT00000194</nct_id>
</id_info>
<brief_title>Neurobiology of Opioid Dependence: 3 - 3</brief_title>
<official_title>Neurobiology of Opioid Dependence: 3</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to study the effects of cycloserine on naloxone-precipitated
opiate withdrawal.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<start_date>January 1993</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Behavioral, subjective, measures of naloxone-preci</measure>
</primary_outcome>
<primary_outcome>
<measure>Phsyiological, neuroendocrine measures of naloxone</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Cycloserine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marc I Rosen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>August 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 5, 2016</last_update_submitted>
<last_update_submitted_qc>May 5, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">May 6, 2016</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>opioid disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cycloserine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000194
org study id: NIDA-00191-3
secondary id: K20DA000191
secondary id: K20-00191-3
nct id: NCT00000194
lead sponsor:
collaborator:
The purpose of this study is to study the effects of cycloserine on naloxone-precipitated
opiate withdrawal.
primary purpose: Treatment
masking: Double
measure: Behavioral, subjective, measures of naloxone-preci
measure: Phsyiological, neuroendocrine measures of naloxone
intervention type: Drug
intervention name: Cycloserine
criteria:
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc I Rosen, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Cycloserine
|
NCT0000xxxx/NCT00000195.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000195</url>
</required_header>
<id_info>
<org_study_id>NIDA-00191-4</org_study_id>
<secondary_id>K20DA000191</secondary_id>
<secondary_id>K20-00191-4</secondary_id>
<nct_id>NCT00000195</nct_id>
</id_info>
<brief_title>Neurobiology of Opioid Dependence: 4 - 4</brief_title>
<official_title>Neurobiology of Opioid Dependence: 4</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on
the response to yohimbine in healthy volunteers.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<start_date>January 1993</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<intervention_model>Crossover Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Behavioral, physiological, neuroendocrine response to yohimine</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Naltrexone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marc I Rosen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>August 2015</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>May 5, 2016</last_update_submitted>
<last_update_submitted_qc>May 5, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">May 6, 2016</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>opioid disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Naltrexone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000195
org study id: NIDA-00191-4
secondary id: K20DA000191
secondary id: K20-00191-4
nct id: NCT00000195
lead sponsor:
collaborator:
The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on
the response to yohimbine in healthy volunteers.
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Behavioral, physiological, neuroendocrine response to yohimine
intervention type: Drug
intervention name: Naltrexone
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc I Rosen, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
|
NCT0000xxxx/NCT00000196.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000196</url>
</required_header>
<id_info>
<org_study_id>NIDA-00191-5</org_study_id>
<secondary_id>K20DA000191</secondary_id>
<secondary_id>K20-00191-5</secondary_id>
<nct_id>NCT00000196</nct_id>
</id_info>
<brief_title>Neurobiology of Opioid Dependence: 5 - 5</brief_title>
<official_title>Neurobiology of Opioid Dependence: 5</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to determine the effect of acute naltrexone pretreatment on the
response to yohimbine in healthy volunteers.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<start_date>January 1993</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Behavioral, physiological, neuroendocrine response to yohimbine</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Naltrexone</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marc I Rosen, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 2013</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>June 2, 2015</last_update_submitted>
<last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">June 3, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Naltrexone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000196
org study id: NIDA-00191-5
secondary id: K20DA000191
secondary id: K20-00191-5
nct id: NCT00000196
lead sponsor:
collaborator:
The purpose of this study is to determine the effect of acute naltrexone pretreatment on the
response to yohimbine in healthy volunteers.
primary purpose: Treatment
masking: Double
measure: Behavioral, physiological, neuroendocrine response to yohimbine
intervention type: Drug
intervention name: Naltrexone
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc I Rosen, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
|
NCT0000xxxx/NCT00000197.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000197</url>
</required_header>
<id_info>
<org_study_id>NIDA-00238-2</org_study_id>
<secondary_id>K20DA000238</secondary_id>
<nct_id>NCT00000197</nct_id>
</id_info>
<brief_title>Propranolol for Treatment of Cocaine Addiction - 2</brief_title>
<official_title>Propranolol for Treatment of Cocaine Addiction</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<oversight_info>
<has_dmc>No</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the safety and efficacy of propanolol in the early
treatment of cocaine dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>January 1987</start_date>
<completion_date type="Actual">January 2002</completion_date>
<primary_completion_date type="Actual">January 2002</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Side effects</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine use</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine withdrawal</measure>
</primary_outcome>
<primary_outcome>
<measure>Cocaine craving</measure>
</primary_outcome>
<primary_outcome>
<measure>Mood and anxiety</measure>
</primary_outcome>
<primary_outcome>
<measure>Clinical improvement</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Propranolol</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>25 Years</minimum_age>
<maximum_age>49 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kyle Kampman, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>January 11, 2017</last_update_submitted>
<last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
<last_update_posted type="Estimate">January 12, 2017</last_update_posted>
<responsible_party>
<name_title>Kyle Kampman</name_title>
<organization>University of Pennsylvania</organization>
</responsible_party>
<keyword>cocaine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Propranolol</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000197
org study id: NIDA-00238-2
secondary id: K20DA000238
nct id: NCT00000197
lead sponsor:
collaborator:
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of propanolol in the early
treatment of cocaine dependence.
primary purpose: Treatment
measure: Side effects
measure: Cocaine use
measure: Cocaine withdrawal
measure: Cocaine craving
measure: Mood and anxiety
measure: Clinical improvement
intervention type: Drug
intervention name: Propranolol
criteria:
gender: All
minimum age: 25 Years
maximum age: 49 Years
healthy volunteers: No
last name: Kyle Kampman, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
name title: Kyle Kampman
organization: University of Pennsylvania
mesh term: Cocaine-Related Disorders
mesh term: Propranolol
|
NCT0000xxxx/NCT00000198.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000198</url>
</required_header>
<id_info>
<org_study_id>NIDA-00238-3</org_study_id>
<secondary_id>K20DA000238</secondary_id>
<secondary_id>K02-00238-3</secondary_id>
<nct_id>NCT00000198</nct_id>
</id_info>
<brief_title>Piracetam for Treatment of Cocaine Addiction - 3</brief_title>
<official_title>Piracetam for Treatment of Cocaine Addiction</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine
dependent subjects maintained on piracetam while they are residing in an inpatient addictions
treatment research unit and to subsequently follow these patients in an eight week open label
assessment of piracetam in an outpatient treatment program.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>October 1996</start_date>
<completion_date type="Actual">October 1997</completion_date>
<primary_completion_date type="Actual">October 1997</primary_completion_date>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Pulse, blood pressure</measure>
</primary_outcome>
<primary_outcome>
<measure>Adverse effects</measure>
</primary_outcome>
<primary_outcome>
<measure>High, anxiety, withdrawal</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Piracetam</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kyle Kampman, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2013</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>October 5, 2015</last_update_submitted>
<last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">October 6, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Principal Investigator</responsible_party_type>
<investigator_affiliation>University of Pennsylvania</investigator_affiliation>
<investigator_full_name>Kyle Kampman</investigator_full_name>
<investigator_title>Principal Investigator</investigator_title>
</responsible_party>
<keyword>cocaine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Piracetam</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000198
org study id: NIDA-00238-3
secondary id: K20DA000238
secondary id: K02-00238-3
nct id: NCT00000198
lead sponsor:
collaborator:
The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine
dependent subjects maintained on piracetam while they are residing in an inpatient addictions
treatment research unit and to subsequently follow these patients in an eight week open label
assessment of piracetam in an outpatient treatment program.
primary purpose: Treatment
measure: Pulse, blood pressure
measure: Adverse effects
measure: High, anxiety, withdrawal
intervention type: Drug
intervention name: Piracetam
criteria:
gender: Male
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Kyle Kampman, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Kyle Kampman
investigator title: Principal Investigator
mesh term: Cocaine-Related Disorders
mesh term: Piracetam
|
NCT0000xxxx/NCT00000199.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000199</url>
</required_header>
<id_info>
<org_study_id>NIDA-00238-4</org_study_id>
<secondary_id>K20DA000238</secondary_id>
<secondary_id>K02-00238-4</secondary_id>
<nct_id>NCT00000199</nct_id>
</id_info>
<brief_title>Piracetam for Treatment of Cocaine Addiction, Phase II - 4</brief_title>
<official_title>Piracetam for Treatment of Cocaine Addiction, Phase II</official_title>
<sponsors>
<lead_sponsor>
<agency>University of Pennsylvania</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of Pennsylvania</source>
<brief_summary>
<textblock>
The purpose of this study is to follow patients in Phase I of an inpatient study in an eight
week open label assessment of piracetam in an outpatient treatment program.
</textblock>
</brief_summary>
<overall_status>Withdrawn</overall_status>
<phase>Phase 1</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Drug use</measure>
</primary_outcome>
<primary_outcome>
<measure>Adverse effects</measure>
</primary_outcome>
<primary_outcome>
<measure>Clinical status</measure>
</primary_outcome>
<enrollment type="Actual">0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Piracetam</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Kyle Kampman, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>University of Pennsylvania</affiliation>
</overall_official>
<location>
<facility>
<name>University of Pennsylvania</name>
<address>
<city>Philadelphia</city>
<state>Pennsylvania</state>
<zip>19104 6178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>March 2017</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>March 28, 2017</last_update_submitted>
<last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
<last_update_posted type="Actual">March 30, 2017</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>cocaine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Piracetam</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000199
org study id: NIDA-00238-4
secondary id: K20DA000238
secondary id: K02-00238-4
nct id: NCT00000199
lead sponsor:
collaborator:
The purpose of this study is to follow patients in Phase I of an inpatient study in an eight
week open label assessment of piracetam in an outpatient treatment program.
primary purpose: Treatment
measure: Drug use
measure: Adverse effects
measure: Clinical status
intervention type: Drug
intervention name: Piracetam
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kyle Kampman, M.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility:
country: United States
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
mesh term: Piracetam
|
NCT0000xxxx/NCT00000200.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000200</url>
</required_header>
<id_info>
<org_study_id>NIDA-03818-1</org_study_id>
<secondary_id>R01-03818-1</secondary_id>
<nct_id>NCT00000200</nct_id>
</id_info>
<brief_title>Cocaine Effects in Humans: Physiology and Behavior - 1</brief_title>
<official_title>Cocaine Effects in Humans: Physiology and Behavior</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Columbia University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<oversight_info>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
The purpose of this study is to compare the effects of buprenorphine or methadone maintenance
on cocaine taking and on the physiological and subjective effects of cocaine, including
cocaine craving, in opiate-dependent cocaine users.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>January 1997</start_date>
<completion_date type="Actual">January 1998</completion_date>
<primary_completion_date type="Actual">January 1998</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>N/A</allocation>
<intervention_model>Single Group Assignment</intervention_model>
<primary_purpose>Treatment</primary_purpose>
<masking>Double (Participant, Care Provider)</masking>
</study_design_info>
<primary_outcome>
<measure>Interaction of cocaine and meds on cardio</measure>
<time_frame>3 hr</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Interaction of cocaine & meds on coc's subjective</measure>
<time_frame>3 hr</time_frame>
</primary_outcome>
<primary_outcome>
<measure>Effects of medication on cocaine craving</measure>
<time_frame>3 hr</time_frame>
</primary_outcome>
<enrollment type="Actual">19</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Methadone</intervention_name>
<description>normal maintenance dose</description>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Marian Fischman, Ph.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Columbia University</affiliation>
</overall_official>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10023</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<results_reference>
<citation>Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64.</citation>
<PMID>8819498</PMID>
</results_reference>
<verification_date>October 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>January 11, 2017</last_update_submitted>
<last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
<last_update_posted type="Estimate">January 12, 2017</last_update_posted>
<keyword>self-administration</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Methadone</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000200
org study id: NIDA-03818-1
secondary id: R01-03818-1
nct id: NCT00000200
lead sponsor:
collaborator:
has dmc: Yes
The purpose of this study is to compare the effects of buprenorphine or methadone maintenance
on cocaine taking and on the physiological and subjective effects of cocaine, including
cocaine craving, in opiate-dependent cocaine users.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Interaction of cocaine and meds on cardio
time frame: 3 hr
measure: Interaction of cocaine & meds on coc's subjective
time frame: 3 hr
measure: Effects of medication on cocaine craving
time frame: 3 hr
intervention type: Drug
intervention name: Methadone
description: normal maintenance dose
criteria:
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Marian Fischman, Ph.D.
role: Principal Investigator
affiliation: Columbia University
facility:
country: United States
citation: Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64.
PMID: 8819498
mesh term: Cocaine-Related Disorders
mesh term: Methadone
|
NCT0000xxxx/NCT00000201.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000201</url>
</required_header>
<id_info>
<org_study_id>NIDA-05196-1</org_study_id>
<secondary_id>R01-05196-1</secondary_id>
<nct_id>NCT00000201</nct_id>
</id_info>
<brief_title>Pharmacological Modulation of Cocaine Effects - 1</brief_title>
<official_title>Pharmacological Modulation of Cocaine Effects</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Johns Hopkins University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<brief_summary>
<textblock>
The purpose of this study is to conduct human laboratory studies of possible cocaine
interactions with various potential treatment medications.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<completion_date>December 2001</completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Selegiline</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Female</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>George Bigelow, Ph.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Johns Hopkins University</affiliation>
</overall_official>
<location>
<facility>
<name>Johns Hopkins University (BPRU) Bayview Campus</name>
<address>
<city>Baltimore</city>
<state>Maryland</state>
<zip>21224 6823</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>October 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>January 11, 2017</last_update_submitted>
<last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
<last_update_posted type="Estimate">January 12, 2017</last_update_posted>
<keyword>cocaine dependence</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Selegiline</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000201
org study id: NIDA-05196-1
secondary id: R01-05196-1
nct id: NCT00000201
lead sponsor:
collaborator:
The purpose of this study is to conduct human laboratory studies of possible cocaine
interactions with various potential treatment medications.
primary purpose: Treatment
intervention type: Drug
intervention name: Selegiline
criteria:
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: George Bigelow, Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility:
country: United States
mesh term: Cocaine-Related Disorders
mesh term: Selegiline
|
NCT0000xxxx/NCT00000202.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000202</url>
</required_header>
<id_info>
<org_study_id>NIDA-05626-1</org_study_id>
<secondary_id>R01DA005626</secondary_id>
<secondary_id>R01-05626-1</secondary_id>
<nct_id>NCT00000202</nct_id>
</id_info>
<brief_title>Buprenorphine Maintenance for Opioid Addicts - 1</brief_title>
<official_title>Buprenorphine Maintenance for Opioid Addicts</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in
treatment of opiate and cocaine dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>August 1988</start_date>
<completion_date type="Actual">May 2006</completion_date>
<primary_completion_date type="Actual">May 2006</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>65 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Thomas R Kosten, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>J Nerv Mental Dis, 1993, 181(6) pp. 358-364; NIDA Res Mono 1993, 132:100 ; Am J Psychiatary 1993, 150:1755; Am J Addictions 1994, 3: 43-48; NIDA Res Mono 1994, 141:79; NIDA Res Mono 1995, in press.</citation>
</reference>
<verification_date>April 2020</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>April 28, 2020</last_update_submitted>
<last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
<last_update_posted type="Actual">April 29, 2020</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Opioid-Related Disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000202
org study id: NIDA-05626-1
secondary id: R01DA005626
secondary id: R01-05626-1
nct id: NCT00000202
lead sponsor:
collaborator:
The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in
treatment of opiate and cocaine dependence.
primary purpose: Treatment
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Thomas R Kosten, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
citation: J Nerv Mental Dis, 1993, 181(6) pp. 358-364; NIDA Res Mono 1993, 132:100 ; Am J Psychiatary 1993, 150:1755; Am J Addictions 1994, 3: 43-48; NIDA Res Mono 1994, 141:79; NIDA Res Mono 1995, in press.
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000203.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000203</url>
</required_header>
<id_info>
<org_study_id>NIDA-05626-2</org_study_id>
<secondary_id>R01DA005626</secondary_id>
<secondary_id>R01-05626-2</secondary_id>
<nct_id>NCT00000203</nct_id>
</id_info>
<brief_title>Buprenorphine Maintenance for Opioid Addicts - 2</brief_title>
<official_title>Buprenorphine Maintenance for Opioid Addicts</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence
and cocaine abuse.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>August 1988</start_date>
<completion_date type="Actual">May 2006</completion_date>
<primary_completion_date type="Actual">May 2006</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Drug use</measure>
</primary_outcome>
<primary_outcome>
<measure>Withdrawal symptoms</measure>
</primary_outcome>
<primary_outcome>
<measure>Psychological symptoms</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Thomas R Kosten, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Schottenfeld RS, Pakes J, Ziedonis D, Kosten TR. Buprenorphine: dose-related effects on cocaine and opioid use in cocaine-abusing opioid-dependent humans. Biol Psychiatry. 1993 Jul 1-15;34(1-2):66-74. doi: 10.1016/0006-3223(93)90258-f.</citation>
<PMID>8373940</PMID>
</reference>
<verification_date>April 2020</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>April 28, 2020</last_update_submitted>
<last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
<last_update_posted type="Actual">April 29, 2020</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Opioid-Related Disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000203
org study id: NIDA-05626-2
secondary id: R01DA005626
secondary id: R01-05626-2
nct id: NCT00000203
lead sponsor:
collaborator:
The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence
and cocaine abuse.
primary purpose: Treatment
measure: Drug use
measure: Withdrawal symptoms
measure: Psychological symptoms
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas R Kosten, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
citation: Schottenfeld RS, Pakes J, Ziedonis D, Kosten TR. Buprenorphine: dose-related effects on cocaine and opioid use in cocaine-abusing opioid-dependent humans. Biol Psychiatry. 1993 Jul 1-15;34(1-2):66-74. doi: 10.1016/0006-3223(93)90258-f.
PMID: 8373940
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000204.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000204</url>
</required_header>
<id_info>
<org_study_id>NIDA-05626-3</org_study_id>
<secondary_id>R01DA005626</secondary_id>
<secondary_id>R01-05626-3</secondary_id>
<nct_id>NCT00000204</nct_id>
</id_info>
<brief_title>Buprenorphine Maintenance for Opioid Addicts - 3</brief_title>
<official_title>Buprenorphine Maintenance for Opioid Addicts</official_title>
<sponsors>
<lead_sponsor>
<agency>Yale University</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>Yale University</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate buprenorphine in a medical maintenance model three
times a week.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>August 1988</start_date>
<completion_date type="Actual">May 2006</completion_date>
<primary_completion_date type="Actual">May 2006</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Drug use</measure>
</primary_outcome>
<primary_outcome>
<measure>Retention</measure>
</primary_outcome>
<primary_outcome>
<measure>Withdrawal symptoms</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>N/A</minimum_age>
<maximum_age>N/A</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Thomas R Kosten, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>VA Connecticut Healthcare System</affiliation>
</overall_official>
<location>
<facility>
<name>VA Connecticut Healthcare System</name>
<address>
<city>New Haven</city>
<state>Connecticut</state>
<zip>06519</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>April 2020</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>April 28, 2020</last_update_submitted>
<last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
<last_update_posted type="Actual">April 29, 2020</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Opioid-Related Disorders</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000204
org study id: NIDA-05626-3
secondary id: R01DA005626
secondary id: R01-05626-3
nct id: NCT00000204
lead sponsor:
collaborator:
The purpose of this study is to evaluate buprenorphine in a medical maintenance model three
times a week.
primary purpose: Treatment
measure: Drug use
measure: Retention
measure: Withdrawal symptoms
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas R Kosten, M.D.
role: Principal Investigator
affiliation: VA Connecticut Healthcare System
facility:
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000205.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000205</url>
</required_header>
<id_info>
<org_study_id>NIDA-06082-1</org_study_id>
<secondary_id>R18DA006082</secondary_id>
<secondary_id>R18-06082-1</secondary_id>
<nct_id>NCT00000205</nct_id>
</id_info>
<brief_title>Buprenorphine Maintenance Protocol - 1</brief_title>
<official_title>Buprenorphine Maintenance Protocol</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of California, Los Angeles</source>
<brief_summary>
<textblock>
The purpose of this study is to compare the efficacy of buprenorphine versus methadone.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>October 1990</start_date>
<completion_date type="Actual">September 1993</completion_date>
<primary_completion_date type="Actual">March 1993</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Retention</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate use</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate craving</measure>
</primary_outcome>
<primary_outcome>
<measure>Adverse events</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within
the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and
/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hynotics. Acute
hepatitis. Other medical conditions that deem participation to be unsafe
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Walter Ling, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Friends Research Institute, Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Friends Research Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90025</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.</citation>
<PMID>8624183</PMID>
</reference>
<reference>
<citation>Compton PA, Ling W, Charuvastra VC, Wesson DR. Buprenorphine as a pharmacotherapy for cocaine abuse: a review of the evidence. J Addict Dis. 1995;14(3):97-114. doi: 10.1300/J069v14n03_07.</citation>
<PMID>8555282</PMID>
</reference>
<reference>
<citation>Compton PA, Ling W, Wesson DR, Charuvastra VC, Wilkins J. Urine toxicology as an outcome measure in drug abuse clinical trials: must every sample be analyzed? J Addict Dis. 1996;15(2):85-92. doi: 10.1300/J069v15n02_07.</citation>
<PMID>8704003</PMID>
</reference>
<verification_date>July 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>July 7, 2016</last_update_submitted>
<last_update_submitted_qc>July 7, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">July 11, 2016</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000205
org study id: NIDA-06082-1
secondary id: R18DA006082
secondary id: R18-06082-1
nct id: NCT00000205
lead sponsor:
collaborator:
The purpose of this study is to compare the efficacy of buprenorphine versus methadone.
primary purpose: Treatment
masking: Double
measure: Retention
measure: Opiate use
measure: Opiate craving
measure: Adverse events
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Walter Ling, M.D.
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
facility:
country: United States
citation: Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence. Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.
PMID: 8624183
citation: Compton PA, Ling W, Charuvastra VC, Wesson DR. Buprenorphine as a pharmacotherapy for cocaine abuse: a review of the evidence. J Addict Dis. 1995;14(3):97-114. doi: 10.1300/J069v14n03_07.
PMID: 8555282
citation: Compton PA, Ling W, Wesson DR, Charuvastra VC, Wilkins J. Urine toxicology as an outcome measure in drug abuse clinical trials: must every sample be analyzed? J Addict Dis. 1996;15(2):85-92. doi: 10.1300/J069v15n02_07.
PMID: 8704003
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000206.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000206</url>
</required_header>
<id_info>
<org_study_id>NIDA-06082-2</org_study_id>
<secondary_id>R18DA006082</secondary_id>
<secondary_id>R18-06082-2</secondary_id>
<nct_id>NCT00000206</nct_id>
</id_info>
<brief_title>Clinical Rescue Protocol - 2</brief_title>
<official_title>Clinical Rescue Protocol</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of California, Los Angeles</source>
<brief_summary>
<textblock>
The purpose of this study is to detect increasing medication dose results in heroin cessation
for patients still using, to determine if decreasing medication dose in patients unable to
tolerate medication dose increases retention, and to determine if blood levels of methadone
or buprenorphine correlate with clinical response.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>April 1991</start_date>
<primary_completion_date type="Actual">August 2005</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Retention</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate use</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate craving</measure>
</primary_outcome>
<primary_outcome>
<measure>Adverse events</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within
the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or
nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute
hepatitis. Other medical conditions that deem participation to be unsafe.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Walter Ling, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Friends Research Institute, Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Friends Research Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90025</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Ling W, Shoptaw S, Wesson D, Rawson RA, Compton M, Klett CJ. Treatment effectiveness score as an outcome measure in clinical trials. NIDA Res Monogr. 1997;175:208-20. No abstract available.</citation>
<PMID>9467800</PMID>
</reference>
<verification_date>November 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>November 3, 2016</last_update_submitted>
<last_update_submitted_qc>November 3, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">November 6, 2016</last_update_posted>
<keyword>Opioid</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000206
org study id: NIDA-06082-2
secondary id: R18DA006082
secondary id: R18-06082-2
nct id: NCT00000206
lead sponsor:
collaborator:
The purpose of this study is to detect increasing medication dose results in heroin cessation
for patients still using, to determine if decreasing medication dose in patients unable to
tolerate medication dose increases retention, and to determine if blood levels of methadone
or buprenorphine correlate with clinical response.
primary purpose: Treatment
masking: Double
measure: Retention
measure: Opiate use
measure: Opiate craving
measure: Adverse events
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Walter Ling, M.D.
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
facility:
country: United States
citation: Ling W, Shoptaw S, Wesson D, Rawson RA, Compton M, Klett CJ. Treatment effectiveness score as an outcome measure in clinical trials. NIDA Res Monogr. 1997;175:208-20. No abstract available.
PMID: 9467800
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000207.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000207</url>
</required_header>
<id_info>
<org_study_id>NIDA-06082-3</org_study_id>
<secondary_id>R18DA006082</secondary_id>
<secondary_id>R18-06082-3</secondary_id>
<nct_id>NCT00000207</nct_id>
</id_info>
<brief_title>Multicenter Clinical Trial of Buprenorphine - 3</brief_title>
<official_title>Multicenter Clinical Trial of Buprenorphine</official_title>
<sponsors>
<lead_sponsor>
<agency>University of California, Los Angeles</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
</sponsors>
<source>University of California, Los Angeles</source>
<brief_summary>
<textblock>
The purpose of this study is to test the efficacy and safety of buprenorphine.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in
the 1 year extension)
</textblock>
</detailed_description>
<overall_status>Completed</overall_status>
<start_date>May 1992</start_date>
<primary_completion_date type="Actual">April 1997</primary_completion_date>
<phase>Phase 3</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<allocation>Randomized</allocation>
<primary_purpose>Treatment</primary_purpose>
<masking>Double</masking>
</study_design_info>
<primary_outcome>
<measure>Retention</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate use</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate craving</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

M/F, ages 21-50. opiate dependence according to DSM-IV criteria. Self-reported use within
the last 30 days. Agreeable to conditions of the study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or
nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute
hepatitis. Other medical conditions that deem participation to be unsafe.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Walter Ling, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Friends Research Institute, Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Friends Research Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90025</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>1) Bup maintenance Tx of opiate dependence: A multicenter randomized tiral (Addiction, submitted) 2) Bup as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996;5(3): 220-222.. (1) Buprenorphine maintenance treatment of opiate dependence: A multicenter randomized trial ( Addiction, submitted). (2) Buprenorphine as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996; 5(3):220-222.</citation>
</reference>
<verification_date>July 2016</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>July 7, 2016</last_update_submitted>
<last_update_submitted_qc>July 7, 2016</last_update_submitted_qc>
<last_update_posted type="Estimate">July 11, 2016</last_update_posted>
<keyword>Buprenorphine</keyword>
<keyword>Opioid</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000207
org study id: NIDA-06082-3
secondary id: R18DA006082
secondary id: R18-06082-3
nct id: NCT00000207
lead sponsor:
collaborator:
The purpose of this study is to test the efficacy and safety of buprenorphine.
12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in
the 1 year extension)
allocation: Randomized
primary purpose: Treatment
masking: Double
measure: Retention
measure: Opiate use
measure: Opiate craving
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Walter Ling, M.D.
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
facility:
country: United States
citation: 1) Bup maintenance Tx of opiate dependence: A multicenter randomized tiral (Addiction, submitted) 2) Bup as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996;5(3): 220-222.. (1) Buprenorphine maintenance treatment of opiate dependence: A multicenter randomized trial ( Addiction, submitted). (2) Buprenorphine as a pharmacotherapy for opiate addiction: What dose provides a therapeutic response? (Am J Add 1996; 5(3):220-222.
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000208.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000208</url>
</required_header>
<id_info>
<org_study_id>NIDA-06082-4</org_study_id>
<secondary_id>R18-06082-4</secondary_id>
<nct_id>NCT00000208</nct_id>
</id_info>
<brief_title>Methadone/Buprenorphine Cross-Over Study - 4</brief_title>
<official_title>Methadone/Buprenorphine Cross-Over Study</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<brief_summary>
<textblock>
The purpose of this study is to explore ways to cross patients over from methadone to
buprenorphine.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>February 1992</start_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>None (Open Label)</masking>
</study_design_info>
<primary_outcome>
<measure>Drug use</measure>
</primary_outcome>
<primary_outcome>
<measure>Withdrawal symptoms</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate craving</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the
last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or
nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute
hepatitis. Other medical conditions that deem participation to be unsafe.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Walter Ling, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Friends Research Institute, Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Friends Research Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90025</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>September 1993</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 16, 2005</last_update_submitted>
<last_update_submitted_qc>August 16, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">August 17, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000208
org study id: NIDA-06082-4
secondary id: R18-06082-4
nct id: NCT00000208
lead sponsor:
The purpose of this study is to explore ways to cross patients over from methadone to
buprenorphine.
primary purpose: Treatment
masking: None (Open Label)
measure: Drug use
measure: Withdrawal symptoms
measure: Opiate craving
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Walter Ling, M.D.
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
facility:
country: United States
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000209.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000209</url>
</required_header>
<id_info>
<org_study_id>NIDA-06082-5</org_study_id>
<secondary_id>R18-06082-5</secondary_id>
<nct_id>NCT00000209</nct_id>
</id_info>
<brief_title>Buprenorphine Dosing Interval - 5</brief_title>
<official_title>Buprenorphine Dosing Interval</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<brief_summary>
<textblock>
The purpose of this study is to explore the feasibility of extending the dosing interval of
well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week
dosing.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>November 1992</start_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
<masking>Single</masking>
</study_design_info>
<primary_outcome>
<measure>Drug use</measure>
</primary_outcome>
<primary_outcome>
<measure>Withdrawal symptoms</measure>
</primary_outcome>
<primary_outcome>
<measure>Opiate and cocaine craving</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Opioid-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the
last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or
nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute
hepatitis. Other medical conditions that deem participation to be unsafe.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>21 Years</minimum_age>
<maximum_age>50 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Walter Ling, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Friends Research Institute, Inc.</affiliation>
</overall_official>
<location>
<facility>
<name>Friends Research Institute</name>
<address>
<city>Los Angeles</city>
<state>California</state>
<zip>90025</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3): 220-222). (1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3):220-222).</citation>
</reference>
<verification_date>September 1994</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 16, 2005</last_update_submitted>
<last_update_submitted_qc>August 16, 2005</last_update_submitted_qc>
<last_update_posted type="Estimate">August 17, 2005</last_update_posted>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Opioid-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000209
org study id: NIDA-06082-5
secondary id: R18-06082-5
nct id: NCT00000209
lead sponsor:
The purpose of this study is to explore the feasibility of extending the dosing interval of
well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week
dosing.
primary purpose: Treatment
masking: Single
measure: Drug use
measure: Withdrawal symptoms
measure: Opiate and cocaine craving
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: No
last name: Walter Ling, M.D.
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
facility:
country: United States
citation: 1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3): 220-222). (1) Buprenorphine as a pharmacotherapy for opiate addiction. What dose provides a therapeutic response? (An J Add 1996; 5(3):220-222).
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000210.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000210</url>
</required_header>
<id_info>
<org_study_id>NIDA-06116-1</org_study_id>
<secondary_id>R18-06116-1</secondary_id>
<nct_id>NCT00000210</nct_id>
</id_info>
<brief_title>Treatment Efficacy for Drug Abuse and AIDS Prevention - 1</brief_title>
<official_title>Treatment Efficacy for Drug Abuse and AIDS Prevention</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Mclean Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<brief_summary>
<textblock>
The purpose of this study is to assess the safety and effectiveness of buprenorphine for
treatment of concurrent intravenous heroin and cocaine dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>September 1989</start_date>
<completion_date type="Actual">February 1996</completion_date>
<primary_completion_date type="Actual">February 1996</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<condition>Heroin Dependence</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>26 Years</minimum_age>
<maximum_age>41 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jack Mendelson, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Mclean Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>McLean Hospital, Dept. of Psychiatry</name>
<address>
<city>Belmont</city>
<state>Massachusetts</state>
<zip>2178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2002</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>January 11, 2017</last_update_submitted>
<last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
<last_update_posted type="Estimate">January 12, 2017</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>opioid addiction</keyword>
<keyword>cocaine addiction</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Substance-Related Disorders</mesh_term>
<mesh_term>Cocaine-Related Disorders</mesh_term>
<mesh_term>Heroin Dependence</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000210
org study id: NIDA-06116-1
secondary id: R18-06116-1
nct id: NCT00000210
lead sponsor:
collaborator:
The purpose of this study is to assess the safety and effectiveness of buprenorphine for
treatment of concurrent intravenous heroin and cocaine dependence.
primary purpose: Treatment
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: Male
minimum age: 26 Years
maximum age: 41 Years
healthy volunteers: No
last name: Jack Mendelson, M.D.
role: Principal Investigator
affiliation: Mclean Hospital
facility:
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Cocaine-Related Disorders
mesh term: Heroin Dependence
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000211.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000211</url>
</required_header>
<id_info>
<org_study_id>NIDA-06116-2</org_study_id>
<secondary_id>R18-06116-2</secondary_id>
<nct_id>NCT00000211</nct_id>
</id_info>
<brief_title>Treatment Efficacy for Drug Abuse and AIDS Prevention - 2</brief_title>
<official_title>Treatment Efficacy for Drug Abuse and AIDS Prevention</official_title>
<sponsors>
<lead_sponsor>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</lead_sponsor>
<collaborator>
<agency>Mclean Hospital</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>National Institute on Drug Abuse (NIDA)</source>
<brief_summary>
<textblock>
The purpose of this study is to assess the safety and effectiveness of buprenorphine for
treatment of concurrent intravenous heroin and cocaine dependence.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>September 1989</start_date>
<completion_date type="Actual">February 1996</completion_date>
<primary_completion_date type="Actual">February 1996</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<condition>Heroin Dependence</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Buprenorphine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>Male</gender>
<minimum_age>26 Years</minimum_age>
<maximum_age>41 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Jack Mendelson, M.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Mclean Hospital</affiliation>
</overall_official>
<location>
<facility>
<name>McLean Hospital, Dept. of Psychiatry</name>
<address>
<city>Belmont</city>
<state>Massachusetts</state>
<zip>2178</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2002</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>January 11, 2017</last_update_submitted>
<last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
<last_update_posted type="Estimate">January 12, 2017</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Substance-Related Disorders</mesh_term>
<mesh_term>Cocaine-Related Disorders</mesh_term>
<mesh_term>Heroin Dependence</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Buprenorphine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000211
org study id: NIDA-06116-2
secondary id: R18-06116-2
nct id: NCT00000211
lead sponsor:
collaborator:
The purpose of this study is to assess the safety and effectiveness of buprenorphine for
treatment of concurrent intravenous heroin and cocaine dependence.
primary purpose: Treatment
intervention type: Drug
intervention name: Buprenorphine
criteria:
gender: Male
minimum age: 26 Years
maximum age: 41 Years
healthy volunteers: No
last name: Jack Mendelson, M.D.
role: Principal Investigator
affiliation: Mclean Hospital
facility:
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Cocaine-Related Disorders
mesh term: Heroin Dependence
mesh term: Buprenorphine
|
NCT0000xxxx/NCT00000212.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000212</url>
</required_header>
<id_info>
<org_study_id>NIDA-06234-1</org_study_id>
<secondary_id>R01DA006234</secondary_id>
<secondary_id>R01-06234-1</secondary_id>
<nct_id>NCT00000212</nct_id>
</id_info>
<brief_title>IV Cocaine Abuse: A Laboratory Model - 1</brief_title>
<official_title>IV Cocaine Abuse: A Laboratory Model</official_title>
<sponsors>
<lead_sponsor>
<agency>New York State Psychiatric Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>Columbia University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>New York State Psychiatric Institute</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of desipramine DMI maintenance on
cocaine taking and on the physiological and subjective effects of cocaine, including cocaine
craving.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>July 1987</start_date>
<completion_date type="Actual">July 1988</completion_date>
<primary_completion_date type="Actual">July 1988</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Amount cocaine self-administered</measure>
</primary_outcome>
<primary_outcome>
<measure>Direct cocaine effects (cardiovascular, subjective</measure>
</primary_outcome>
<primary_outcome>
<measure>Interaction of cocaine and DMI on cardio measures</measure>
</primary_outcome>
<primary_outcome>
<measure>Interaction of cocaine/DMI on coc's subjective</measure>
</primary_outcome>
<primary_outcome>
<measure>Effects of DMI on cocaine craving</measure>
</primary_outcome>
<primary_outcome>
<measure>Drug use during outpatient DMI maintenance</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Desipramine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Richard Foltin, Ph.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Columbia University</affiliation>
</overall_official>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10023</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<reference>
<citation>Fischman MW, Foltin RW, Nestadt G, Pearlson GD. Effects of desipramine maintenance on cocaine self-administration by humans. J Pharmacol Exp Ther. 1990 May;253(2):760-70.</citation>
<PMID>2338656</PMID>
</reference>
<verification_date>December 2012</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 27, 2015</last_update_submitted>
<last_update_submitted_qc>August 27, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">August 31, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>crack cocaine</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Desipramine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000212
org study id: NIDA-06234-1
secondary id: R01DA006234
secondary id: R01-06234-1
nct id: NCT00000212
lead sponsor:
collaborator:
collaborator:
The purpose of this study is to evaluate the effects of desipramine DMI maintenance on
cocaine taking and on the physiological and subjective effects of cocaine, including cocaine
craving.
primary purpose: Treatment
measure: Amount cocaine self-administered
measure: Direct cocaine effects (cardiovascular, subjective
measure: Interaction of cocaine and DMI on cardio measures
measure: Interaction of cocaine/DMI on coc's subjective
measure: Effects of DMI on cocaine craving
measure: Drug use during outpatient DMI maintenance
intervention type: Drug
intervention name: Desipramine
criteria:
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Richard Foltin, Ph.D.
role: Principal Investigator
affiliation: Columbia University
facility:
country: United States
citation: Fischman MW, Foltin RW, Nestadt G, Pearlson GD. Effects of desipramine maintenance on cocaine self-administration by humans. J Pharmacol Exp Ther. 1990 May;253(2):760-70.
PMID: 2338656
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
mesh term: Desipramine
|
NCT0000xxxx/NCT00000213.xml
|
<clinical_study>
<!-- This xml conforms to an XML Schema at:
https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
<required_header>
<download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>https://clinicaltrials.gov/ct2/show/NCT00000213</url>
</required_header>
<id_info>
<org_study_id>NIDA-06234-2</org_study_id>
<secondary_id>R01DA006234</secondary_id>
<secondary_id>R01-06234-2</secondary_id>
<nct_id>NCT00000213</nct_id>
</id_info>
<brief_title>IV Cocaine Abuse: A Laboratory Model - 2</brief_title>
<official_title>IV Cocaine Abuse: A Laboratory Model</official_title>
<sponsors>
<lead_sponsor>
<agency>New York State Psychiatric Institute</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>National Institute on Drug Abuse (NIDA)</agency>
<agency_class>NIH</agency_class>
</collaborator>
<collaborator>
<agency>Columbia University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>New York State Psychiatric Institute</source>
<brief_summary>
<textblock>
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine
taking and on the physiological and subjective effects of cocaine, including cocaine craving.
</textblock>
</brief_summary>
<overall_status>Completed</overall_status>
<start_date>April 1990</start_date>
<completion_date type="Actual">April 1991</completion_date>
<primary_completion_date type="Actual">April 1991</primary_completion_date>
<phase>Phase 2</phase>
<study_type>Interventional</study_type>
<has_expanded_access>No</has_expanded_access>
<study_design_info>
<primary_purpose>Treatment</primary_purpose>
</study_design_info>
<primary_outcome>
<measure>Direct cocaine effects</measure>
</primary_outcome>
<primary_outcome>
<measure>Interaction of cocaine/fluox. on cardio measures</measure>
</primary_outcome>
<primary_outcome>
<measure>Interaction of cocaine/fluox. on coc's subjective</measure>
</primary_outcome>
<primary_outcome>
<measure>Effects of fluoxetine on cocaine craving</measure>
</primary_outcome>
<primary_outcome>
<measure>Drug use during outpatient fluoxetine maintenance</measure>
</primary_outcome>
<enrollment>0</enrollment>
<condition>Cocaine-Related Disorders</condition>
<intervention>
<intervention_type>Drug</intervention_type>
<intervention_name>Fluoxetine</intervention_name>
</intervention>
<eligibility>
<criteria>
<textblock>
Please contact site for information.
</textblock>
</criteria>
<gender>All</gender>
<minimum_age>18 Years</minimum_age>
<maximum_age>45 Years</maximum_age>
<healthy_volunteers>No</healthy_volunteers>
</eligibility>
<overall_official>
<last_name>Richard Foltin, Ph.D.</last_name>
<role>Principal Investigator</role>
<affiliation>Columbia University</affiliation>
</overall_official>
<location>
<facility>
<name>Columbia University</name>
<address>
<city>New York</city>
<state>New York</state>
<zip>10023</zip>
<country>United States</country>
</address>
</facility>
</location>
<location_countries>
<country>United States</country>
</location_countries>
<verification_date>December 2012</verification_date>
<study_first_submitted>September 20, 1999</study_first_submitted>
<study_first_submitted_qc>September 20, 1999</study_first_submitted_qc>
<study_first_posted type="Estimate">September 21, 1999</study_first_posted>
<last_update_submitted>August 27, 2015</last_update_submitted>
<last_update_submitted_qc>August 27, 2015</last_update_submitted_qc>
<last_update_posted type="Estimate">August 28, 2015</last_update_posted>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>intravenous abuse</keyword>
<condition_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Cocaine-Related Disorders</mesh_term>
</condition_browse>
<intervention_browse>
<!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm -->
<mesh_term>Fluoxetine</mesh_term>
</intervention_browse>
<!-- Results have not yet been posted for this study -->
</clinical_study>
|
download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT00000213
org study id: NIDA-06234-2
secondary id: R01DA006234
secondary id: R01-06234-2
nct id: NCT00000213
lead sponsor:
collaborator:
collaborator:
The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine
taking and on the physiological and subjective effects of cocaine, including cocaine craving.
primary purpose: Treatment
measure: Direct cocaine effects
measure: Interaction of cocaine/fluox. on cardio measures
measure: Interaction of cocaine/fluox. on coc's subjective
measure: Effects of fluoxetine on cocaine craving
measure: Drug use during outpatient fluoxetine maintenance
intervention type: Drug
intervention name: Fluoxetine
criteria:
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Richard Foltin, Ph.D.
role: Principal Investigator
affiliation: Columbia University
facility:
country: United States
responsible party type: Sponsor
mesh term: Cocaine-Related Disorders
mesh term: Fluoxetine
|
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